Visual, dimensional, functional and materials analysis could not be performed as the device was not returned.Manufacturing records and complaint history were not able to be reviewed because no lot was provided.The torque wrench used to tighten the blocker during implant surgery was disposed of by the physician; it is unknown if the wrench was properly working.From the surgical technique: the surgeon must discuss all physical and psychological limitations inherent to the use of the device with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion must be directed to the issues of premature weight-bearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and make the patient aware of possible adverse effects.For patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.The plausible root cause of the reported event is unknown at this time due to lack of returned explants.Possible root causes include: excessive load due to unstable construct.Excessive load due to patient anatomy/pathology.Set screws not tightened correctly.
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