Patient weight is unknown.Udi: (b)(4).Device is a combined implant and its instrument.Due to intra-operative issues, the implant device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.Part se-1515ti, bme lot bmese160235: manufacturing date or release to warehouse date: july 07, 2016.A non-conformance report was generated during production for five (5) insertion sticks rejected for voids and one (1) miscut stick.A non-conformance report was generated during production for two (2) crooked implants found during visual inspection.A non-conformance report was generated during production for six (6) oversized sliders.Relevance to complaint condition cannot be determined unless the product is returned for investigation.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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