A case/charge sheet was received to identify part number and patient information.It is unknown the nature of the alleged failure.It is unknown if revision surgery was preformed.Patient's current condition is unknown.Dhr review and product investigation cannot be completed, as multiple attempts have been made to recover the product and/or product information.It is unknown if the patient complied with post-op care instructions.The patient's activity level will dictate the longevity of the implant.Review of labeling notes: "possible adverse events: bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Postoperative fracture due to trauma, defects or poor bone stock." postoperative warnings the patient should be advised that implants may bend, break or loosen despite restriction in activity.The root cause is unknown, as multiple attempts have been made to acquire additional information to no avail.No conclusions can be drawn.
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