The associated complaint device was not returned.Without the actual product involved and/or device information, a manufacturing review cannot be performed and our investigation cannot proceed.The clinical/medical team concluded, although requested no clinical supporting documents have been provided to conduct a thorough analysis of this case.No medical assessment can be rendered at this time.A revision procedure has not been reported.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
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