Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: left breast prosthesis deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast reconstruction procedure with a mentor smooth round moderate profile 700cc saline breast prosthesis that deflated after implantation. Deflation of the patient? S left breast prosthesis was confirmed by a doctor? S physical examination. As a result, the patient will undergo explantation on (b)(6) 2020. The reported implantation date is after the expiration date of the device. The implantation date will be reported as received by mentor. If clarification on the implantation date is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5