Catalog Number 2911-06545 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Pain (1994); No Information (3190)
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Event Date 02/27/2019 |
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 will not be 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) 2019 it was reported to k2m, inc.That six polyaxial screws broke at the shaft approximately 1-3 months post- operatively.A portion of the broken shaft remains in the patient.
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Manufacturer Narrative
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Manufacturing records were not able to be reviewed as lot numbers were not available.It is possible that the sporadic flexion motion could have created excessive force on the construct, causing the screws at the caudal most level to fracture at the shaft.Additional patient activities could have caused the construct to weaken prior to the event.However, since the implants were not available for investigation, a root cause cannot be determined conclusively.
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Event Description
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Physician reported that six polyaxial screws broke at the shaft approximately 1-3 months postoperatively.A portion of the broken shaft remains in the patient.Patient reported pain.Revision surgery has not been scheduled.
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Search Alerts/Recalls
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