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: capsular contracture baker grade iv. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a (b)(6) year-old hispanic female patient who underwent a breast augmentation primary with 550cc smooth mentor memorygel breast implant has experienced postoperative left-sided capsular contracture, baker grade iv, confirmed by a physician. As a result, the patient underwent explantation on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5