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Model Number GRAFTPRO, GRAFT PREP BOARD |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Event Description
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On (b)(6) 2023, it was reported by a distributor via sems-06059959 that an ar-2950d graft prep board had missing screws.It was stated that the screw was found and had no effect on the patient during surgery.This was discovered during an unspecified procedure, with no patient harm.
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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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Search Alerts/Recalls
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