Date of event is approximately one year ago additional device product codes: mni, mnh, kwp, kwq this report is for one (1) unknown end cap.Part and lot numbers are unknown.Without a specific part and lot numbers, the udi is not available.Device is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(510k): unknown, as specific part and lot numbers for end cap is not provided.Patient code (b)(4) is used as the package was missing an end cap which led to the surgeon putting in the screw without an end cap.The patient eventually needed a revision surgery prompted by a loosening screw.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Upon receipt of the additional information this complaint was reviewed and it was detected that this reported device (locking cap) requires its own complaint.Therefore a new complaint (b)(4) has been opened and this report for locking cap is retracted and will be reported under the new complaint (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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