Company was informed of an implant removal surgery that was to be performed 2 months following an akin osteotomy procedure in the 1st ray.X-rays demonstrate lack of bone alignment and are suggestive of bone instability at the surgical site.No immediate post-op imaging was provided.Swelling was attributed to the unstable fixation of the surgical site.Removal surgery was performed successfully the following week.The actual device could not be examined as it was not provided to the company.A product investigation was performed for this device.Based on internal analysis of records and procedures, there is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Based on the investigation of all available data, it is concluded that this event was the outcome of an inappropriate surgical fixation which resulted in an unstable implantation site.The instructions for use include precautions and recommendations for the selection of appropriate surgical technique, implant size, configuration, and surgical site preparation.Although the company does not believe that the device caused or contributed to the injury, as an implant removal surgery was performed, this event is being reported out of an abundance of caution.Company continues to monitor these events as part of post market activities.
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