B3 date of event: the exact event date is unknown.D6a implant date: the exact implant date is unknown, according to the patient, it was implanted in (b)(6) 2022.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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