Catalog Number 7601-10001 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Date 02/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been 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 patient presented with a possible set screw back-out.The patient reportedly had a possible set screw back-out approximately 4 months post-op.
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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 was completed as the lot number has been identified/confirmed in this case.Since the set screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Insufficient rod reduction could contribute to a compromised rod to screw interface which could have led to the failure.However, a specific cause for this event could not be confirmed.
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Event Description
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On (b)(6) 2018 it was reported to k2m, inc.That a patient presented with a possible set screw back-out.The patient reportedly had a possible set screw back-out approximately 3 months post-op.
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Search Alerts/Recalls
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