The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that it has been communicated that no clinical documents are available.Therefore, no thorough clinical assessment of the reported issue can be rendered.Should additional information be provided, the clinical/medical investigation task will be reopened.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Infection is a complication that can be associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the devices or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.
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