Though revision surgery occurred, pathology department would not release device, and the devices were not returned.Device is not available for evaluation.Additionally, no event radiographs of the device were provided for analysis.Photo of the fractured screw confirmed the event.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the longevity the degree of post lateral pseudarthrosis, patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.).Root cause or specific failure mode cannot be determined.
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As part of a retrospective review spanning 2019-2021 given by an orthopedic medical group, it was reported that a patient received a plf with bilateral posterior fixation from l5-s1.Revision surgery was performed on (b)(6) 2022.Photograph was provided of one of the s1 bone screws that fractured.No initial surgery information, patient information or event information were provided.
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