Upon completion of an audit of the dj orthopedics de (b)(4); fda issued a finding on 13 december 2018 that "procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established." this report is being submitted as part of djo's efforts to address this finding.One armor fp, acl, lt, l (part number 11-1441-4, lot number 081217) was returned for evaluation.Flexion is good, liners are still good.Hook of the left pad was not sticking.There are no sharp edges on top of the brace that could have caused a cut on user's thigh.It is possible that there was an impact with considerable force to provoke this kind of injury.The device history record (dhr) was reviewed for the reported product.There was no information in the dhr that would indicate a problem that contributed to the reported complaint.Complaint data for similar products and issues going back 9 months has been reviewed.The trend indicates that reported customer complaints are within control.
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