The alif construct consisted of an anterior plate and four bone screws.There were two lots recorded during the initial surgery.It is unknown which lot (s) fractured.Review of the dhrs (p809106a (documented in 2032593-2016-00006), aa321018a) noted that the products were inspected and accepted for use by the quality control department on 10-29-2008 and 09-02-2008 respectively and met all specified parameters of the receiving inspection report with no material non-conformances or manufacturing errors that may have caused or contributed to this mode of failure.The implants remain in-situ, and no further investigation can be completed at this time.The device has been implanted for 21 months.Review of labeling notes: warning, cautions and precautions: "nonunion or pseudoarthrosis, possibly requiring further surgery." "implants are subject to repeated stresses in use, and their strength is limited by the size and shape of the human spine." "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery" radiographs depicting the fracture, confirmed the event.Patient activity at the time or prior to the event is unknown.The degree of spinal instability at s1-l5 level and the stability of the adjacent segment (l4-l5) motion preservation implantation ( pro_disc) is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.The root cause of this reported event has not been determined.
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