INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-08599
- Event Type
- Injury
- Date Received
- May 23, 2025
- Date of Event
- March 30, 2025
- Report Date
- August 21, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S 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: RUPTURE.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON JUL 15, 2025, WITH LOT NUMBER 3381143. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE: NOT OBSERVED. AS PER THE INVESTIGATION PROCEDURE, DEFORMATION AND CREASE WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, D6A, D9, H3
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.
HEALTHCARE PROFESSIONAL REPORTED "MVC" AND "INVAGINATION OF IMPLANT CAPSULE WITH PARTIAL LINGUINE AND KEYHOLE SIGN". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "MVC" AND "INVAGINATION OF IMPLANT CAPSULE WITH PARTIAL LINGUINE AND KEYHOLE SIGN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED "MVC" AND "INVAGINATION OF IMPLANT CAPSULE WITH PARTIAL LINGUINE AND KEYHOLE SIGN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "MVC" AND "INVAGINATION OF IMPLANT CAPSULE WITH PARTIAL LINGUINE AND KEYHOLE SIGN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2260989 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 3381143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention |