Catalog Number F2911-06550 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Information (3190)
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Event Date 08/22/2018 |
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 was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, 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 in which a broken screw was removed approximately 4-6 months post-operatively.Revision took place (b)(6) 2018.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation, and a thorough investigation was completed.The implant was returned, visually and functionally inspected.Upon review of the part, it was observed that the shaft of the screw fractured approximately three threads from the tulip head.
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Event Description
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On (b)(6) 2018 it was reported to k2m, inc.That a revision took place in which a screw was removed approximately 4-6 months post-operatively.Revision took place on (b)(6) 2018.
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Search Alerts/Recalls
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