On the literature article named "the use of a multiplaner, multi-axis external fixator to achieve knee arthrodesis in worst case scenario: a case series", it was reported that, patient 6 developed a wound breakdown 2 months following tsf removal.The wound was successfully treated with irrigation and debridement and closure with a local gastrocnemius muscle flap.
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The device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the data presented in the aged article reported, patient 6 developed a wound breakdown two months following tsf removal.Per the article, the wound was successfully treated with irrigation and debridement and closure with a local gastrocnemius muscle flap.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, 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.Some potential probable causes could be patient reaction or post-operative healing issue.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.
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