Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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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Device report from synthes reports an event in (b)(6) as follows: it was reported on jul.29, 2021, the patient underwent for a revision surgery due to infection.On (b)(6) 2021 the primary fibular reconstruction procedure in the mandible was performed to treat ameloblastoma.Trumatch was applied without surgical delay.It was unknown if the revision surgery completed successfully.The patient outcome unknown.No further information is available.This complaint involves twelve (12) devices.This report is for (1) 2.4mm ti matrixmandible locking screw slf-tpng 8mm.This report is 7 of 12 for (b)(4).Related product complaint: (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H4, h6: product code: 04.503.638.01s, lot number: 80p1388, manufacturing site: bettlach, release to warehouse date: 07 december 2020, expiry date: 01 november 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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