Case Study of Ti6Al4V Pedicle Screw Failures Due To Geometric and Microstructural Aspects

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Engineering Failure Analysis 25 (2012) 133–143

Contents lists available at SciVerse ScienceDirect

Engineering Failure Analysis


journal homepage: www.elsevier.com/locate/engfailanal

Case study of Ti6Al4V pedicle screw failures due to geometric


and microstructural aspects
Sandro Griza a,⇑, Carlos Eduardo C. de Andrade a, Wilton W. Batista a, Eduardo K. Tentardini a,
Telmo R. Strohaecker b
a
Programa de Pós-Graduação em Ciência e Engenharia dos Materiais, Universidade Federal de Sergipe, São Cristóvão, Brazil
b
Programa de Pós-Graduação em Engenharia de Metalúrgica, de Minas e Materiais, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil

a r t i c l e i n f o a b s t r a c t

Article history: Pedicle screws are widely used alternatives to improve the spine fusion in the treatment of
Received 13 March 2012 several spine diseases. However, the screw fracture rates are still high nowadays. Efforts to
Received in revised form 11 May 2012 provide design and material selection should be encouraged. This paper deals with the
Accepted 14 May 2012
analysis of design issues related to failure event of 10 Ti6Al4V pedicle screws explanted
Available online 24 May 2012
from five patients who had rupture before 5 years in use. The objective of this study was
to correlate the mechanical failure with the geometric and microstructural concerns. Bend-
Keywords:
ing fatigue was the main mechanism responsible for the failures. Fractures occurred near
Fatigue
Ti6Al4V
the thread end or at intermediate thread level. In some cases environmental assisted crack-
Pedicle screw ing (EAC) was associated with failure initiation. The formation of lamellar or platelike
microstructure, the small thread root radius and surface roughness were factors related
to failures.
Ó 2012 Elsevier Ltd. All rights reserved.

1. Introduction

The use of pedicle screws in orthopedic surgery was introduced by Boucher in 1959 and popularized in Europe by
Roy-Camille in the 1960s. Basically, the technique involves the insertion of screws into the pedicles of two or more adjacent
vertebrae to provide vertical rods fastening which will restrain vertebral relative motion (Fig. 1). The technique is applied to
enhance vertebrae fusion through the spine posterior stabilization and has been a widely used alternative to treat fractures,
tumors, degenerative diseases, low back pain and sciatica, spondylolisthesis and the spinal deformity correction as well [1,2].
Due to the routine use of pedicles in spinal stabilization surgeries, its morphological studies have been encouraged, since
it is the vertebra portion that has biomechanical advantages with increased use for implant anchorage [3]. The pedicles are
elongated bone portions of the vertebrae and have cross section in tear form. They are disposed crosswise to the spine axis
and in an oblique direction on the cranio-caudal view (Fig. 1). Pedicle contains small amounts of cortical bone surrounding
an inner plentiful cancellous bone. Morphometric studies have shown that pedicle three-dimensional structure is very
complex and varies into the different spine segments. Them, it should not be considered only as a cylindrical bone [4].
Besides the geometric complexity, the pedicle geometric constraint limits the maximum screw diameter and it also
should be considered. The screw cross section is given by the pedicle geometry rather than the imposed external load.
The pedicle screw placement surgery, in its turn, has also some concerns. The insertion access is difficult particularly for
obese people. The surgeon must be highly trained in the methodology to avoid operative and postoperative complications
[5]. These aspects make the prediction of screw/pedicle geometric construction for studies on their mechanical loading a

⇑ Corresponding author. Tel.: +55 79 21056888; fax: +55 79 21056845.


E-mail address: griza@ufs.br (S. Griza).

1350-6307/$ - see front matter Ó 2012 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.engfailanal.2012.05.009
134 S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143

Screw

Rod

Pedicle

(a) (b)
Fig. 1. Sketch of the pedicle screws stabilizing the spine (a), and the upper view of the vertebra (b).

complex work and may also contribute to the considerable fracture incidence [6]. Although the precise failure mechanism is
unclear, it is believed to be related to the excess bending stress, improper position, cyclic loading or delayed bone union [7].
Loosening due to cyclic loading and screw fatigue are commonly cited reasons for mechanical failure [5,8,9]. These failures
sometimes lead to non-union, sagital collapse of the reconstruction and painful kyphosis [7]. Sometimes revision is needed.
Besides all costs related to orthopedic revision surgery, there are some cases reported in the literature of clinical complica-
tions due to revision [10].
Finite element biomechanical studies showed the implant continues to hold up part of the physiological spinal loading
even after a solid fusion and thus continues to experience fatigue loading inside the human body [6]. Some studies have been
dedicated to measure the loads imposed on reconstruction. The findings have shown the pedicle screw fractures are almost
always fatigue and also indicate that higher loads imposed to fixation devices were measured for walking, a normally per-
formed posture which leads to a large number of cyclic loads [11–13].
Currently Ti6Al4V alloy is the most widely used material for pedicle screw manufacture due to its higher fatigue resis-
tance and biocompatibility but it did not eliminate the screw fracture issue. Thus, studies aimed at exploring the factors that
lead to failures should be encouraged.

2. Materials and methods

We analyzed 10 pedicle screws fractured in five patients (cases) explanted before 5 years in use. Stabilizations were from
the thoracic to the lumbar level or only in the lumbar level, respectively for correction of severe spine deformity or low back
pain or sciatica, as shown in Table 1. The screws were sterilized in autoclave before analysis. The screws have between 18
and 22 threads and they were made from Ti6Al4V alloy according to the information of manufacturers. The investigation
consisted of visual analysis of the screw surface aspects, fracture analysis, EDS microprobe and microstructural analysis.
The thread root radius from metallographies was also measured.

2.1. Screw surface aspects and fracture analysis

After cleaning, the screws were subjected to low magnification stereomicroscope and to scanning electron microscope
(SEM) analyses. They also allowed qualitative investigation of the screw surface aspect to identify the fracture plane site
regarding the thread portion.

Table 1
Microstructure and failure analysis results for the five cases of fractured screw.

Case Stabilization Screws a Fracture Fracture mechanisms Microstructure Root radius


level site (mm)
1 Thoracic–lumbar A Third Bending fatigue Lamellar a + b 0.15
B Eleventh Bending fatigue Lamellar a + b 0.15
2 Thoracic–lumbar A First Bending fatigue Platelike a + b 0.3
3 Lumbar A Third Bending fatigue Globular a + b 1.0
B Fourth Bending fatigue Globular a + b 1.0
4 Lumbar A First Bending fatigue, environment assisted crack Lamellar a + b 0.6
B Third Bending fatigue Platelike a + b 0.6
C Seventh Bending brittle fracture Lamellar a + b 0.6
5 Lumbar A Sixth Bending fatigue environment assisted crack Lamellar a + b Sharp corner
B Seventh Bending and torsional fatigue environment assisted crack Lamellar a + b Sharp corner
a
Thread number from screw’s hub.
S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143 135

Fig. 2. SEM images for screws A and B for case 1. (a) SEM analysis showing a smooth fracture surface appearance, with the fracture nucleation starting at the
thread root. (b) Analysis of screw B shows striations characteristics of fatigue observed for the most part of the fracture surface.

Fig. 3. SEM analysis of screw B, case 1. The thread root possess radius of approximately 0.15 mm.

Fig. 4. Two OM images show the microstructure of screw B, case 1. Pictures present lamellar alpha phase and alpha in the beta primary grain boundaries.

2.2. EDS microprobe

EDS microprobe analyses were performed from samples previously polished to identify the alloy constituents.

2.3. Microstructure analysis

Metallographic sections were obtained from the longitudinal screw sections. The samples were performed in order to
measure the thread root radius. To allow this, the outer screw diameters were measured by a caliper (0.05 mm resolution)
136 S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143

before sample mounting. Then, during grinding, the sample thicknesses were controlled to reach the mean section. The sam-
ples were etched by immersion in 0.2% HF, 0.4% HNO3 diluted in water. Images were performed by optical microscopy (OM).

3. Results

Some aspects were whole common: the EDS microprobe analysis showed peaks of titanium, aluminum and vanadium for
all screws and all of them had visible machining marks on the thread sides and roots. Table 1 presents the specific findings
for the five cases. They are explained as following:

Fig. 5. (a) OM image showing smooth fracture surface with beach marks characteristics of fatigue of the case 2 screw A. The crack propagated until the
shear lips end region. (b) SEM analysis shows the fatigue striations. (c) OM shows the 0.05 mm thread root radius. (d) OM image shows the platelike alpha
phase in grain primary beta microstructure.

Fig. 6. (a) Macroscopic analysis shows a screw fracture in the third fillet of screw A in case 3. The image presents the rough machining finish appearance. (b)
Aspect of the machining finish of the screw B, case 3, with 1.0 mm of root radius.
S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143 137

3.1. Case 1

The two screws fractured due to bending fatigue which occurred in the third and eleventh thread cross section, respec-
tively. Both had a smooth fracture surface and fatigue striations (Fig. 2). The thread root radius adjacent to those fractured
was 0.15 mm (Fig. 3). The microstructure is transformed, consisting of lamellar alpha phase and alpha outlining the primary
beta grain boundaries (Fig. 4).

3.2. Case 2

The screw fractured in the first thread cross section. Beach marks and fatigue striations were observed into a large
amount of the fracture surface. A small 0.3 mm thread root radius was seen in a thread adjacent to that fractured (Fig. 5).
The microstructure consists of platelike alpha in grain primary beta.

Fig. 7. Bending fatigue crack propagation appearance of the two analyzed screws for case 3, screw A above and Screw B below. The arrows points to the
fracture nucleation sites. The images showed at right show fatigue striations found in the fracture surface of respective screws.

Fig. 8. Metallographic analysis shows a finely dispersed globular alpha (white) and globular beta (dark) phase found in the screw B of case 3.
138 S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143

3.3. Case 3

Fracture occurred in two screws, respectively, in the third and fourth thread cross section. The screws showed typical
rough machining finish (Fig. 6). The threads were machined with 1.0 mm root radius. The fracture has typical fatigue appear-
ance (Fig. 7). Microstructure consists of finely dispersed globular alpha and beta phase (Fig. 8).

3.4. Case 4

Three broken screws were found in case 4. Fractures suggest bending loads. The screw A had branched secondary cracks
on the lamellar alpha-rich surface layer, typical of environmental assisted cracking (Fig. 9). The screws A and B showed fa-
tigue striations along the fracture surface (Figs. 9 and 10). The third screw C presented brittle fracture aspect related to cleav-
age of the primary beta grains. Cleavage seems like outlining the alpha and beta lamellae (Fig. 11).

3.5. Case 5

Two fractured screws were found in the case 5. Fracture occurred respectively in the seventh and eighth thread cross sec-
tion, adjacent to where they were found thread root sharp corners (Fig. 12). The low magnification fracture surface showed
rough aspect, typical of fractures in materials with coarsened microstructure. The analysis also showed striations indicating
fatigue crack propagation under predominant bending loads in the screw A, and under a combination of bending and torsion
in the screw B respectively (Fig. 13). The formation of alpha phase network outlining the coarse primary beta grain boundary
was found in both screws as well as branching typical of environmental assisted cracking near the fracture nucleation
(Fig. 14). The microstructure is completed by lamellar alpha phase in grain primary beta (Fig. 15).

4. Discussions

This paper was dedicated to verify geometrical and microstructural features concerning the rupture of 10 pedicle screws
in five patients, in order to provide the findings to the material selection and design improvements, identifying factors that
may be controlled in manufacture and allowing decrease of future failure incidences. No other factors as external loading or
biological aspects were evaluated.

Fig. 9. Analysis for screw A in case 4. (a) The arrow in the photography indicates the beach marks emanating from the nucleation site, as by. (b) SEM image
showing fatigue striations. (c) Branches within the nucleation site, indicating environment assisted cracking in the lighter surface layer, typical behavior of
oxidation. (d) OM image showing the microstructure consisting of lamellar alpha phase in grain primary beta.
S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143 139

Fig. 10. Analysis for screw B, case 4: (a) Metallographic image showing the rough fracture aspect. The arrow indicates the nucleation site. (b) SEM analysis
for the region pointed by the arrow showing the crack propagation fatigue striations. (c) OM image shows the microstructure consisting of platelike alpha
phase in grain primary beta.

The EDS microprobe analysis confirmed that all screws were manufactured from Ti6Al4V alloy. The macroscopic fracture
morphology showed a smooth surface along the largest part of the section from the thread roots and following to the final
fracture generally associated to shear rupture of the diametrically opposite thread section. This feature suggests predomi-
nance of bending external load, the predominant type of external load find in pedicle screws [6,7]. In only one screw (case
5) it was found an aspect indicative of torsion.
Striations indicative of fatigue propagation were found in nine fractures. Only one screw had brittle fracture with cleavage
facets outlining the lamellar microstructure in primary beta grains. Lamellar or platelike microstructure was found in 8 out
of 10 fractured screws. Such microstructure occurs when the Ti6Al4V alloy is heated above the beta transition and then
quenched (lamellar) or cooled moderately (platelike). According to the biomedical material standards (ISO 5832-3, ASTM
F136), the Ti6Al4V alloy microstructure should be a fine dispersion of alpha and beta phase, resulting from processing in
the alpha and beta field. Continuous alpha network in primary beta grain boundary should be avoided, and should not be
coarse, elongated lamellar or platelike alpha. The globular fine grain dispersion improves the Ti6Al4V alloy fatigue proper-
ties. Results reported in the literature shows something like 40% fatigue strength reduction of the lamellar structure when
compared to the finely dispersed in Ti6Al4V alloy [14]. Since it is difficult to increase the screw diameter due to the pedicles
geometric constraints, it is recommended to use the most resistant materials to prevent pedicle screw fractures [8].
Fractures were observed in the cross section between the first and fourth thread from the screw’s hub in 6 screws (cases
1, 2, 3, 4). In the other four screws, fracture takes place in the thread weight intermediated level, between the sixth and elev-
enth thread section. According to the literature, the most observed site of screw failure is at the junction of the screw’s hub
and its threaded portion, the so called thread end [7]. When the screw is fastened until the thread end and thread fixation in
the pedicle cortical wall is stiff enough, the screw undergoes a cantilever beam condition in which it is expected the highest
bending moment will be exactly at that junction. However, in some cases, for reasons of the spine fixation system compo-
nents assembling (the screw itself and rods), the screw will not be fixed until the thread end, some threads become out of the
cortical bone. Thus, the load is transferred to the thread immediately in contact with the cortical bone. On the other hand,
fractures were also observed in the thread intermediate level, as expected to a simply supported beam condition. When the
cortical support is less effective, the bending stress should be transferred to the intermediate level.
Branched secondary cracks indicative of environmentally assisted cracks encouraging the fatigue propagation were found
in three screws (cases 4 and 5). Transformed lamellar Ti6Al4V alloy presents corrosion fatigue strength reduction in tests
140 S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143

Fig. 11. Analysis for screw C, case 4: (a) OM shows the brittle fracture appearance (arrow points to nucleation site). (b) SEM analysis indicates a cleavage
appearance of the primary beta grains, according to the microstructure (c), formed by lamellar alpha phase and alpha in primary beta grain boundaries.

Fig. 12. At left, macroscopic analysis for screw A, case 5 fracture. Rupture zone throughout the screw section. At right, of thread root features: sharp corner
and undulations denoting rough surface finish.

simulating body environment [15], denoting a tendency to high sensitivity to environmentally assisted cracks [16]. Some
studies indicate the possibility of embrittlement and environmentally assisted cracking in titanium alloys concerning the
oxygen content [17–19]. The metallographies showed a transformed layer with coarse alpha phase (the so called ‘‘a case’’).
It is indicative of thermal process oxygen diffusion [20]. Heat treatment in titanium alloys should be performed in an inert
atmosphere to avoid surface embrittlement.
Those eight screws that showed transformed microstructure also showed small thread root radius, reaching a sharp cor-
ner in two of them. Is it not known a standard which limits the lowest possible pedicle screws thread root radius. However,
the ISO 5835 standard is applied to metallic bone screws for general use and states the radius varies according to the screw
nominal diameter. For those diameters studied here, the radius would be near 0.8 mm. The lower the root radius, the higher
the stress concentration effect, and it decreases fatigue performance. Therefore, it is important to establish limits to the ped-
icle screw thread root radius.
S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143 141

Fig. 13. At left, OM images for fracture in screw A and B for case 5: the image upward shows the rough fracture of the screw A. The image below shows the
screw B rupture due to a combination of bending and torsional loads. At right, SEM analysis with the arrows indicates nucleation sites. Fatigue crack
propagation striations are shown in both screws.

Fig. 14. Metallographic analysis for screw A (left) and B (right) for case 5. Branched features indicating environment assisted cracks and microstructure
consisting of platelike alpha in grain primary beta outlined by an alpha network.

All screws showed rough machining surface finish, and in the case 3, fractures were associated only to the surface finish.
Studies have demonstrated better screw fixation due to surface roughness which enhances the cells growth on titanium al-
loys [21,22]. Apparently, there is an optimal roughness range that induces osseointegration increase. The cells need anchor-
age points on the implant surface to begin proliferation and ensure biofixation. If the metal surface roughness is much
smaller than the cell size, there may be lack of fixation sites. On the other hand, if the implant has many peaks and valleys,
but these have smooth surfaces, the cells will not be well fixed either. Recent studies have shown the level of roughness that
provides increased biocompatibility is in the nanometric range [23,24]. Anyway, studies associating the rough machining
surface to the better implant stabilization are not available in the literature to our knowledge. On the other hand, it is wide-
spread that the rough surface finish adversely affects the fatigue performance of high strength materials.
142 S. Griza et al. / Engineering Failure Analysis 25 (2012) 133–143

Fig. 15. MO analysis for screw A, case 5 showing the microstructure formed by lamellar alpha phase in grain primary beta.

The Marine’s empirical Law [25] suggests that the fatigue strength of a given piece is proportional to the product of the
fatigue strength of the manufacturing material and several reduction factors. The reduction factor takes into account aspects
such as: surface finish of the piece, size, load, work temperature, reliability and miscellaneous-effects. Stress concentration,
microstructure and all those other factors that can be quantified is given by miscellaneous-effects. In the present study, it is
possible to estimate the microstructure, surface effect and stress concentration factor. Transformed lamellar microstructure
compared to finely dispersed alpha + beta gives reduction of about 0.6 [14,26,27]. Roughly machined surface finish compared
to a smooth one gives reduction of about 0.7 [28,29]. The stress concentration factor is a function of the form factor and it is
dependent on the given root radius and the diameter ratio [25,30,31]. Considering a grooved round bar with 4 mm minor
diameter and diameter ratio 2 in bending, a reduction of the root radius from 0.8 mm to 0.2 mm provides a reduction of
about 0.6. The three factors are in the same order and can reduce by about 80% the fatigue strength of the pedicle screws.
Pedicle screws should be preferably machined with a smooth surface finish and smooth fillet root radius, manufactured
from Ti6Al4V alloy with microstructure formed by alpha + beta finely dispersed particles. Perhaps, the ISO 5835 standard
could be extended to the case to ensure a minimal fillet root radius enhancing the fatigue performance of pedicle screws.

5. Conclusions

Pedicle screws are critical elements for fracture since their strength section is limited by the pedicle section. In our study
bending fatigue was found as the main cause of fractures and it may occur either on the screw threaded end as at the middle
threaded level. In the design of pedicle screws should be considered the better microstructural and geometric features
(thread root radius and surface finish) in order to reduce the failure rate. Pedicle screws should be preferably machined with
a smooth surface finish and smooth fillet root radius, manufactured from Ti6Al4V alloy with microstructure formed by al-
pha + beta finely dispersed particles.

Acknowledgements

The authors would like to thank the financial support of CAPES, CNPq, FINEP and FAPITEC.

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