Catalog Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 12/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
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Event Description
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On (b)(6) 2018 it was reported to k2m, inc.That a screw backed-out, loosened or disengaged 7 months post -operatively.Patient was revised (b)(6) 2018.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject implants were not available for evaluation, and the specific product information could not be confirmed.The incident was confirmed through evaluation of post-operative x-rays, wherein it appears that the four screws placed at the c7 and t1 levels were disengaged from the bone.The patient was revised, the subject screws were removed and replaced, and the construct was extended to c2.
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Event Description
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On (b)(6) 2018 it was reported to k2m, inc, that polyaxial screws pulled out approximately seven months post-operatively.
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Search Alerts/Recalls
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