Catalog Number 1101-03518F |
Device Problems
Material Fragmentation (1261); Insufficient Information (3190)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 08/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, manufacturer will file a supplemental report indicating the findings.
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Event Description
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On (b)(6) 2019 it was reported to k2m, inc.That the outer collet of a screw was damaged during locking.The implant remains in the patient within the construct.
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Manufacturer Narrative
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The outer collet fragment was returned, visually and microscopically inspected.The surgeon was satisfied with the rest of the construct and decided not to replace the subject screw.Manufacturing and inspection records of the subject lot were reviewed and no relevant discrepancies were found.It is possible the locker was not properly aligned with the screw head, resulting in an unbalanced force that caused the outer collet to fracture.
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Event Description
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On (b)(6) 2019 it was reported to k2m, inc.That the outer collet of a screw was damaged during locking.The implant remains in the patient within the construct.
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Search Alerts/Recalls
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