Catalog Number 1101-40001 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Information (3190)
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Event Date 06/14/2016 |
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 product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as no lot number has been identified/confirmed in this case.Since the occipital plate remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.During the revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during the revision.No definitive root cause can be determined.Device remains in patient.
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Event Description
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It was reported to k2m, inc.On (b)(6) 2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.It was reported that the patient heard a squeaking noise in his neck a few months post-op.During the first revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during this revision.During the second revision the implants were removed and the assembly swage of the anchor was compromised so the nut was separated from the rest of the anchor.Most of the damage observed on the anchor and threads is consistent with extrication.There is a significant abrasion on the bottom of the hook portion of the anchor.The abrasions on the rod and on the anchor with lot cyey are consistent with loading from a rod slip.No definitive root cause could be determined.Patient fall likely contributed to the loosening and dislocation of the nuts.The manufacturing and inspection records were reviewed and no discrepancies were found.
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Event Description
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It was reported to k2m, inc.On (b)(6) 2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.Patient fell and was revised again on (b)(6) 2016.
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Search Alerts/Recalls
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