No product has been returned for investigation nor were x-ray films provided to confirm the event.A review of the product labeling has been performed.Potential adverse events and complications: "as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "these devices can break when subjected to the increased load associated with delayed union or nonunion.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." post-operative warnings: "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.".
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On (b)(6) 2017, a patient underwent a vertebral body replacement (vbr) procedure at t11-l1 levels.Post-operatively, the implant was reported to have migrated.Patient underwent a revision procedure on (b)(6) 2017, where the implant was replaced.No patient injury was reported.
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