Manufacturer was made aware that during a patient planned revision, the surgeon was not able to remove the connector set screws which are usually removed and replaced.The surgeon decided to leave the connector in the patient, was not able to re-tighten the set screws as they were stripped and put a cross connector in to stabilize the construct.
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Manufacturer was made aware that during a patient planned revision, the surgeon was not able to remove the connector set screws which are usually removed and replaced.The surgeon decided to leave the connector in the patient, was not able to re-tighten the set screws as they were stripped and put a cross connector in to stabilize the construct.The device evaluation is anticipated, but not yet begun.Manufacturer will file a follow-up report once new information becomes available.Disposition of device to be determined.
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Follow-up #1/final report issued to include additional information as indicated below.Follow-up actions indicate that the patient is doing well, k2m inc does not expect to receive additional information in regards to this case and then, considers this to be a close-out report.The implants remain in the patient and could not be evaluated.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.The incident could not be recreated.Cross threading could have contributed to the incident.The set screws of the implants are not designed to be removed.Attempting to remove the set screws can damage the threads of the connector and is consistent with misuse.There is not a firm conclusion regarding this event since the subject part(s) were not returned for evaluation.The risk (common risk analysis, risk-000 rev 7: hazard analysis, pha lines: 109-124: rod connector is damaged and/or breaks, lines 145-156: set screw is damaged, cross threaded, and/or breaks, and lines 157-158: set screw does not function as intended) was reviewed and determined that addresses the scenario described in this case.The probability and severity associated with these hazards are found to be accurately assigned.No edits are required.Technique: the surgical technique guide and ifu are accurate and available to the surgeon - no edits required.Device remains in patient.
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