Model Number UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021, it was reported by a sales representative via sems that the middle peg of an ar-9236-02pp univers vaultlock glenoid trial cracked-off (happened previously).This was discovered during use with no impact to the patient.
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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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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 (b)(6) 2021, it was reported by a sales representative via sems that the middle peg of an ar-9236-02pp univers vaultlock glenoid trial cracked-off (happened previously).This was discovered during use with no impact to the patient.
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Manufacturer Narrative
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Complaint confirmed, the device was returned with a broken central peg.The cause of the event is undetermined, however a likely cause is user-applied mechanical forces.
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Search Alerts/Recalls
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