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: rupture. 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 who underwent primary breast augmentation with a 325cc mentor memorygel breast implant experienced left sided rupture post procedure. The rupture was noted through ultrasound. As a result, an explant was performed on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5