Catalog Number 3704-0-050 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 10/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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Patient presented to surgeon complaining of pain, revision hip surgery to determine cause of pain.Cables removed from femur bone graft and cerclage wire applied.
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Manufacturer Narrative
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An event regarding patient pain involving a dall miles cable was reported.The event was not confirmed.Method and results: device evaluation could not be performed as no items were returned.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review indicated there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the return of device, operative reports, x-rays, patient history and follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
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Event Description
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Patient presented to surgeon complaining of pain, revision hip surgery to determine cause of pain.Cables removed from femur bone graft and cerclage wire applied.
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Search Alerts/Recalls
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