Catalog Number 2911-06540 |
Device Problems
Break (1069); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 10/01/2018 |
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 two broken screws approximately 2 years post-operatively.The patient was revised on (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.Upon review of the parts, it was observed that the screws had sheared immediately distal to the screw neck.Analysis of the shear faces revealed a smooth and shiny surface, which is consistent with the effects of sudden brittle fracture.Compounding forces at the event site may have contributed to the cantilever forces already present at the distal end of the construct.
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Event Description
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On (b)(6) 2018 it was repord to k2m, inc.That a revision took place due to two broken screws approximately 2 years post-operatively.The patient was revised on (b)(6) 2018.
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Search Alerts/Recalls
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