Catalog Number 2901-10001 |
Device Problems
Device Slipped (1584); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 08/16/2018 |
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 09.04.2018 it was reported to k2m, inc that a revision took place in which a screw backed-out.Loosened, disengaged approximately 4 to 6 months post-operatively.A portion of the screw remains in the patient.Revision took place (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 revision took place in which a screw backed out.Loosend, disengaged approximately 4 to 6 months post-operatively.A portion of the screw remains in the patient.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.Upon further investigation it was concluded that the device did not contribute to this incident.
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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 set screw, it was observed that the screw displayed radial damage consistent with the effects of reduction of the rod during tightening of the set screw.This can absorb the torque applied during the tightening phase, and allow for less than ideal locking forces.
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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 backed out.Loosend, disengaged approximately 4 to 6 months post-operatively.Revision took place (b)(6) 2018.
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Search Alerts/Recalls
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