Model Number 48289999 |
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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Manufacturer Narrative
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Lot additional information- the following lot numbers were also provided as potentially being this device: wjt, wd6, wzc.Additional information has been requested.If additional information is received, a supplemental report will be provided.
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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 blocker.
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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 blocker.
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Manufacturer Narrative
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D.3: manufacturing entity was corrected from 'stryker spine-france' to 'stryker spine-us' d.4 was previously reported with 4 possible lots and the record has been updated to reflect the lot received.D.9 was updated to reflect product return.H.4 was updated to reflect manufacturing date.
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Manufacturer Narrative
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Visual inspection noted indentations on the blocker which indicate that the blocker may have been over-tightened during the initial surgery or was removed and re-implanted during the initial surgery.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 blocker.
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Search Alerts/Recalls
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