The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms it cannot be determined to what extent the patient¿s history of spinal fusion, increased combined anteversion and soft tissue laxity had on her dislocation.The root cause of the dislocation post second revision cannot be determined and it cannot be concluded that the dislocation is associated with a mal-performance of the implant.The patient impact beyond the dislocation and reduction cannot be determined.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include improper surgical technique, device selection or patient anatomy.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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