H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that patient specific clinically relevant documentation has not been provided as of the date of this medical investigation and it was communicated that there was ¿no more information¿.The current patient health status remains unknown.The clinical root cause of the reported screw loose could not be further assessed.The patient outcomes beyond that which was documented in the article could not be determined.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.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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