Model Number BIO-COMP SWVLK 3.5X 15.8MM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during a surgery the swivelock anchors could not be fixed one after the other.Anchors could be screwed in directly after drilling but came out of the bone again immediately.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device, ar-2323-1.It was not necessary to switch the surgical technique or do a second surgery.
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Search Alerts/Recalls
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