Requests for model & lot number have been requested but not received.Upon receipt a review of batch records will be made to look for any deviations and results of the final product release.Additional case information has been requested to support the investigation and assessment of technical and procedural aspects.Follow up interviews have been made to attempt to determine if the surgical technique may have contributed to the outcome.Clinical experience has shown a combination of factors such as complex procedure, graft configuration, patient anatomy, and suture placement can impact final clinical outcome.
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