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Model Number 3.5MM PUSHLOCK, BIOCOMP, SELF-PUNCHING |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
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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On 3/18/2024, it was reported by a sales representative via email that an ar-1926bcsp biocomposite pushlock anchor eyelet broke on impaction.The broken fragments were removed from inside the patient.This was discovered during an rcr procedure on (b)(6)2024.Additional information received on 3/26/2024: there was no delay in the procedure, and additional anesthesia was not needed.The patient suffered no negative effects.
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Search Alerts/Recalls
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