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Model Number DRIVER, T10 HEXALOBE |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2023 |
Event Type
malfunction
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Event Description
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On 12/22/2023, it was reported by a sales representative via sems (b)(4) that an ar-8944dh t10 hexalobe driver twisted while screwing in the implant.The case was completed successfully using a second driver.The patient was not harmed.
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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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