It was communicated from a distributer a revision surgery took place to remove one locking cap that allegedly become dislodged postop.Patients current condition is unknown.Radiograph received confirming event.During the review of the dhr for lot ma92912f , it was concluded that the product was inspected and accepted for use by the quality control department on (b)(6) 2016 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.Intra-operative warnings if the system/construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.Postoperative warnings the patient should be advised that implants may bend, break or loosen despite restriction in activity.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.The locking caps were returned to the manufacturer.At this time, the internal complaint / investigation is open.The root cause is currently unknown.
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