It was reported in the document that 10 patients develop pin tract infections as follows: five patients were grade ii (42.6 %, treated with local care), four were grade iii (33%, treated with oral antibiotics), and one was grade iv (8%, treated with wire retensioning and oral antibiotics.).
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It was documented on a literature review that the patient developed pin tract infection.The unknown taylor spatial frame, 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, complaint history and sterilization documentation 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.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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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