Investigation summary: based on the information available, the cause that contributed to the reported revision surgery cannot be established as the product is not available for analysis.Dhr review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
|