Catalog Number E5112-06550 |
Device Problem
Break (1069)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Information (3190)
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Event Date 08/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject product has not been returned for evaluation.Investigation still in progress.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) 2017 it was reported to k2m, inc.That during surgery the polyaxial screw broke.The fractured component was removed and surgery completed.
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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 the lot number has not been identified/confirmed in this case.Since the fractured components were not returned, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Over torque, impact or force could contribute to premature tab breakage.No single cause could be determined for this event.
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Event Description
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On (b)(6) 2017 it was reported to k2m, inc.That during surgery the screws extended tab broke prematurely resulting in significant delay of surgery.The fractured component was removed and surgery completed.
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Search Alerts/Recalls
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