Catalog Number 603-21028C |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Date 09/28/2017 |
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 11.27.2017 it was reported to k2m, inc.That a revision surgery took place in which a migrated interbody was removed.Revision surgery took place (b)(6) 2017.(related to 3004774118-2017-00218).
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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 theinterbody was retained by the hospital, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.
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Event Description
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On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which a migrated interbody was removed.Revision surgery took place (b)(6) 2017.(related to 3004774118-2017-00218).
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Search Alerts/Recalls
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