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. Since no lot number was provided, no manufacturing record evaluation could be performed. Reason for device explant and/or reoperation: capsular contracture baker grade ii. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
It was reported that a (b)(6) year-old female patient who underwent primary breast augmentation surgery with an 175cc unspecified textured gel breast implant experienced left sided capsular contracture baker grade ii post procedure. As a result, patient had an explantation (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5