Additional information: d4.Model# 15704-075-050.Lot# to00143.Udi# (b)(4).H6.Investigation findings: 3207.Conclusion: 61.H10.Observations: the invictus modular polyaxial reduction tulip pn 16510 and modular screw shank pn 15704-075-050 were visually and physically examined and showed no apparent signs of manufacturing defect although both components showed signs of damage during retrieval.A review of the dhrs indicated no remarkable manufacturing or quality items that would have impacted performance relative to the complaint beyond the intended design.There are no clear indications that the design, manufacturing, or initial quality of the implants contributed to the complaint.The invictus modular polyaxial reduction tulip was returned in an undeployed state, meaning that the collet was in its most proximal state.The ring component showed signs of rod contact which indicates that the collet had been properly pushed distally during insertion with the instrument forcing the shank to be captured properly within the assembly and allowing proper rod lockdown.There were no obvious signs within the tulip or on the collet that indicated material was sheared within the tulip or on the collect reflecting that the rod must had lost lockdown force due to set screw backoff resulting in the instability of the screw construct and subsequent release of the shank from the tulip.The internal components show loading indicators and markings from insertion onto the modular shank and lockdown with a rod.The disassembled individual components were reviewed and did not reflect any shearing or deforming outside of the loading conditions.Failure mode and root cause: construct failure due to non-normalization of the rod to screw and set screws interface.Markings depict that proper lockdown was achieved but the rod was not fully normalized to the screws and set screws, creating a construct that with diminished gripping capacity resulting in a possibility of rod slippage.Normalization of the rod is further complicated when fixating and spanning segments with increased lordosis where the polyaxial range of cranial-caudal motion of the screw may limit the ability to fully normalize to the rod as in l5-s1.
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