The returned spacer was analyzed and visual examination confirmed the event of the patient having a damaged spacer due to a golf cart accident.The returned implant revealed a fractured cam lobe, and tool damage to the spindle, spindle cap, and body of the implant.The damage to the implant was sufficient to prevent functional testing.A labeling review was performed and it did not reveal any anomalies as the instructions for use (ifu) states that device dislodgement, particularly if the patient experiences a traumatic event postoperatively and loosening, fatigue, deformation, breakage or disassembly of the implant, which may require another operation to remove the implant and may require another method of treatment; as well as deformation, breakage or disassembly of the implant, and spinous process fracture are among other risks associated with the procedure.The reported event of the patient having a damaged spacer due to a golf cart accident was confirmed.Visual inspection revealed a fractured cam lobe, and tool damage to the spindle, spindle cap and body of the implant.The damage to the implant was sufficient to prevent functional testing.However, a labelling review found that the reported event is a known risk associated with the use of lumbar spine implants and associated instruments.
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