In a scientific publication, duramaz 2017, "platelet-rich plasma versus exchange intramedullary nailing in treatment of long bone oligotrophic nonunions" it was reported that the patient presented a nonunion and it was treated with the stabilization of the fracture and grafting of the fracture line with autografts.
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It was reported that from the literature review that the patient presented a nonunion and it was treated with the stabilization of the fracture and grafting of the fracture line with autografts.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to abnormal motion over time, friction, high impact on limb or user/procedural variance.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
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