The surgeon and patient opted to perform a revision surgery on (b)(6) 2020.The distributor was unable to provide information surrounding the surgical technique, x-rays, or additional information surrounding the revision outcome and/or care plan.Review of labeling: possible adverse events: 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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A patient underwent spinal surgery consisting of seaspine's mariner pedicle screw system on (b)(6) 2020.On (b)(6) 2020, it was reported that the right l4-l5 set screws separated from the tulip, the left l5 bone screw appeared loose, and the left l4 set screw separated from the construct in the postoperative period.
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