No radiographic images and microbiology/pathology reports provided for review.Review of lhr did not reveal any non conformance for the lot number and serial number.Based on the inspection of the retrieved m6-c implant, in conjunction with data provided, the device had not failed mechanically at the time of removal.There was no evidence of collapse and there was no apparent in vivo loss of retention of the sheath.Destructive examination of the inner surfaces of the device is needed to examine the integrity of the fiber construct and the core.It was reported that infection was suspected, which may have contributed to the noted fluid absorption; however, no lab results were provided.It is therefore not clear if infection played a role in the failure of this procedure.
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