Catalog Number 482802645 |
Device Problem
Migration (4003)
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Patient Problem
Injury (2348)
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Event Date 04/16/2020 |
Event Type
Injury
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Event Description
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It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/ rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the second of the two screws.
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Manufacturer Narrative
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Device history records and complaint history were reviewed and no relevant manufacturing issues or similar complaints were identified.The most likely cause of the reported event is multifactorial: excessive movement by patient post-operatively, post-operative trauma, poor bone quality, non-fusion after 2 years, improper construct.
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Event Description
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It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the second of the two screws.
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Event Description
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It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the second of the two screws.
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Manufacturer Narrative
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D.3: manufacturing entity was corrected from 'stryker spine-france' to 'stryker spine-us'.Section d was updated to reflect product information upon product return.H.4 was updated to reflect manufacturing date.
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Search Alerts/Recalls
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