Catalog Number 47248404050 |
Device Problem
Fracture (1260)
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Patient Problem
No Code Available (3191)
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Event Date 08/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same patient (reference 1822565-2016-04582).
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Event Description
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It is reported that the patient was revised due to fracture of the distal screw implants approximately three weeks post-operatively.The screws were removed and replaced.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.
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Event Description
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It is reported that the patient was revised due to fracture of a distal screw implant approximately three weeks post-operatively.The screw was removed and replaced, and a second screw was also implanted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint sample was evaluated through a device history record review, but the event cannot be confirmed as the complaint sample was not returned for physical evaluation.The device history records were reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined.
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Search Alerts/Recalls
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