Visual inspection: the device was inspected, and it was observed that the screw shank was fractured immediately distal to the proximal ball feature.The fracture face had a high-low cross-section, and abrasions can also be observed on the screw shank threads.The set screw remained properly placed within the screw saddle.Device and complaint history records were reviewed, and one similar complaint was identified.Per surgical technique: potential adverse events: 1.Potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Postoperative 1.Adequately instruct the patient.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.2.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.3.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.The root cause could not be determined conclusively.Incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may have contributed to the failure.Dynamic motion can compound cantilever forces at the proximal screw shank, resulting in fracture.It could not be determined if fusion was achieved.
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