Catalog Number F2911-06550 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 03/26/2018 |
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 has not been returned for evaluation yet.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 revision surgery took place due to a screw break afe approximately 7-9 months post-operatively.Patient was revised on (b)(6) 2018.
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Event Description
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On (b)(6) 2018 it was reported to k2m, inc that a surgery took place in which a fenestrated screw broke approximately nine months post-operatively.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The shaft of the screw was confirmed to be broken approximately 25 millimeters from the head assembly.The fracture face exhibits characteristics consistent with failure in fatigue.It is possible that a lack of supplemental fixation at adjacent levels allowed for a degree of dynamic motion within the construct, contributing to a failure in fatigue.Manufacturing and inspection records of the subject lot were reviewed, and no relevant discrepancies were found.
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Search Alerts/Recalls
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