Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00513; 0001822565-2023-00514; 0001822565-2023-00516; 0002648920-2023-00029.Bone screw self-tapping 6.5 mm dia.40 mm length/00625006540/j6833188; bone screw self-tapping 6.5 mm dia.25 mm length/00625006525/j7051454; bone screw self-tapping 6.5 mm dia.30 mm length/00625006530/j7144345; bone screw self-tapping 6.5 mm dia.35 mm length/00625006535/64129635.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported that during the revision procedure, the screws fell through the cup.There were no health consequences or impact to the patient.Attempts have been made and no further information is available.
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Manufacturer Narrative
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Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
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Event Description
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Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
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Search Alerts/Recalls
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