STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-01857
- Event Type
- Injury
- Date Received
- February 3, 2025
- Date of Event
- November 5, 2024
- Report Date
- February 3, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6 DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON MARCH 03, 2025. WITH LOT NUMBER 2012559. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING AND MISSING PIECE OF SHELL ASSESSED AS INCLUSIVE. AS PER THE INVESTIGATION PROCEDURE, NON PENETRATING NICK WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEVICE RUPTURE.
PHYSICIAN REPORTED IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RELATES TO THE LEFT SIDE.
PHYSICIAN REPORTED IMPLANT RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RELATES TO THE LEFT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1294205 | STYLE 10 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2012559 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |