Adverse event: others: fracture, delayed-union, weakness, bursitis, pain.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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A multi-center retrospective observational study was conducted to obtain post-market clinical data for medtronic spine implantable devices.This data was queried and grouped based on the specific medtronic system used in the surgical procedure and analyzed to establish real-world evidence (rwe) for the performance and safety of the device in question when used as part of standard clinical practice.This data collection is one part of ongoing post-market clinical surveillance activities that are intended to confirm and monitor the safety and performance of the device.This report summarizes the clinical data obtained by medtronic as part of this retrospective observational study.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.As per this clinical evaluation report, it was reported that the patient diagnosed with stenosis, spondylolisthesis, and disc degeneration, underwent a four-level, lumbar, posterior, spine fusion procedure.This patient was implanted with a spinal construct that consisted of the endcap, used as an interbody spacer, and the alleged system for posterior spinal fixation.At 6 months post-operative, there was radiographic evidence of evolving bone consolidation at the interbody fusion levels of l1-l2 and l4-l5.However, at 14-months post-operative, there was evidence of delayed union at l4-l5 with an l5 pedicle fracture and pedicle screw break-out, requiring a revision surgery at 15 months post-operative.This patient experienced developed trochanteric bursitis and experienced continued back pain and lower extremity weakness.It is unknown if these symptoms were alleviated following the revision surgery.
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