Catalog Number 211H7040 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/29/2021 |
Event Type
Injury
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Manufacturer Narrative
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Procode: qhp.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00020 through 3012447612-2022-00026.
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Event Description
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It was reported a revision surgery was performed because the surgeon believed the tether cord had broken post-operatively.However, during the revision, the cord was found to be intact, but some of the set screws did not appear to be locked and were loose during removal, especially at l3.The cord and set screws were removed and replaced.This is report six of seven for this event.
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Manufacturer Narrative
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Data was erroneously entered into h3; there are no changes from the initial report.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: neither the closure top nor the screw was returned for evaluation.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown operational factors, patient factors, or post-op events.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Event Description
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It was reported a revision surgery was performed because the surgeon believed the tether cord had broken post-operatively.However, during the revision, the cord was found to be intact, but some of the set screws did not appear to be locked and were loose during removal, especially at l3.The cord and set screws were removed and replaced.This is report six of seven for this event.
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Search Alerts/Recalls
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