It was reported that, on the literature review "strategies and outcomes in severe open tibial shaft fractures at a major trauma center: a large retrospective case-series", a 31-year old male patient who underwent primary implantation of a taylor spatial frame fixator to treat a severe open tibial shaft fracture experienced nonunion which eventually progressed to a bony union outcome after a revision procedure was performed to replace this system with an unspecified intramedullary nail.The postoperative periods during which the nonunion outcome was diagnosed and the bony union was achieved are unknown.No further information is available.
|
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, in a literature review ", a 31-year old male patient who underwent primary implantation of a taylor spatial frame fixator to treat a severe open tibial shaft fracture experienced nonunion which eventually progressed to a bony union outcome after a revision procedure was performed to replace this system with an unspecified intramedullary nail.The postoperative periods during which the nonunion outcome was diagnosed, and the bony union was achieved are unknown.However, the nonunion of the bone would not be a mal-performance of the product.No further information is available.Without clinical and patient specific information, a thorough medical investigation cannot be performed.The clinical root cause and the impact to the patient beyond that which was documented in the article cannot be confirmed nor concluded.No further medical assessment is warranted at this time.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 excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Internal complaint reference number: (b)(4).
|