Device Problem
Difficult to Remove (1528)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/18/2022 |
Event Type
Injury
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Event Description
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It was reported that during a surgery to remove previously-implanted hardware at the patient's request, the tips of five drivers broke while attempting to remove the final iliac screw.The first eleven screws were successfully removed, but the twelfth screw could not be removed so the tulip was detached and removed, leaving the screw shaft in place.There was a delay associated with attempting to remove the final screw, but there were no impacts associated with the delay.This is report six of six for this event.
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2022-00254 through 3012447612-2022-00259.
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Manufacturer Narrative
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Component, investigation type, findings, and conclusions.Device evaluation: screw was not returned, so device evaluation could not be completed for the screw.Root cause: root cause was unable to be determined.Dhr review: dhr review unable to be completed for the screw as product information is not known.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 that during a surgery to remove previously-implanted hardware at the patient's request, the tips of five drivers broke while attempting to remove the final iliac screw.The first eleven screws were successfully removed, but the twelfth screw could not be removed so the tulip was detached and removed, leaving the screw shaft in place.There was a delay associated with attempting to remove the final screw, but there were no impacts associated with the delay.This is report six of six for this event.
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Search Alerts/Recalls
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