The surgeon has not been able to locate the relevant films or information related to the loosened set screws and reported none of the patients required revisions.No additional details regarding the original surgery, the patient's condition, or treatment plan have been communicated to seaspine.Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
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