Catalog Number 1101-03516M |
Device Problems
Fracture (1260); Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Date 10/31/2017 |
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.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) 2017, it was reported to k2m inc.That a plate had backed out about six months post-operatively.The patient was revised on (b)(6) 2017.
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Manufacturer Narrative
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A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The proximal (tulip head) portion was examined at the fracture face and suggested rapid tension fracture had occurred.Review of the fluoroscopy showed the screw head portion lifted away from the distal screw fracture piece by approximately 6-7mm indicating posterior pull away force was experienced.This suggests that significant reduction force may have been necessary intraoperatively.Overload force or trauma could have contributed to an immediate tension fracture.However, a specific cause for this event could not be confirmed.Further information received indicated that the subject device was the fractured screw instead of the cervical plate that was reported earlier.
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Event Description
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On (b)(6) 2017, it was reported to k2m inc.That a cervical polyaxial screw fracture had occured.The patient was revised on (b)(6) 2017.
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Search Alerts/Recalls
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