Visual, dimensional, material and functional analysis could not be performed as the device associated with this record was not returned.Device history records or complaint history records could not be reviewed as a valid lot number or catalog number was not provided and could not be obtained.It was reported that the patient did not experience any trauma, bone quality is unknown, no x rays were provided, and details of the revision surgery are unknown.The mesa device ifu and surgical technique were reviewed: "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.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." without the device or x rays, a definite cause cannot be determined.The device was implanted for over 7 years.The ifu warns against potential adverse events relating to delayed healing or keeping a device implanted after the patient has healed.Other possible factors include patient bone quality, construct design, and/or patient post op activity.
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