Investigation summary: based on the information available, the cause that contributed to the reported allegations of mechanical issue and malposition cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number and/or facility account number were not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.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.
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