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Model Number 1136.2012 |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was not available for evaluation as it was discarded by the hospital.Additional information provided after the first anchor was deployed, the spacer was deemed to be in an appropriate position.The second anchor was deployed and it was discovered that the spacer had moved roughly 5mm posteriorly and the patient had lost motor function.The surgeon decided to perform a corpectomy to remove the implants.It is possible that the causes could be related to surgical technique, implant sizing, or another unknown issue; however, the exact cause of the reported issue could not be determined.
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Event Description
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It was reported that 2 coalition mis anchors were advanced too far causing the patient to lose motors.The anchors were unable to be retrieved with the removal tool, resulting in the surgeon performing a corpectomy to remove the cage and screws.
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Search Alerts/Recalls
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