H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the attached literature review on "removal of antibiotic cement-coated interlocking nails", was reviewed.It should be noted, the primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent is an off-label use of the implant.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as procedural/user error and/or off- label material used.The contribution of the device to the reported event not could be corroborated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|