MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2024-13080
- Event Type
- Injury
- Date Received
- November 7, 2024
- Date of Event
- October 14, 2024
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001270
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON FEBRUARY 3, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE CORRECT DATE OF EXPLANTATION WAS ON (B)(6) 2025. IN ADDITION, MENTOR ALSO RECEIVED INFORMATION INDICATING THAT THE SUSPECT MEDICAL DEVICE WAS A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501660. TWO LOT NUMBERS WERE PROVIDED FOR THE LEFT IMPLANT (5925648 AND 5931841). FOLLOW-UPS ARE IN PROGRESS TO DETERMINE WHICH IMPLANT REALLY BELONGS TO THE RIGHT BREAST. ON FEBRUARY 18, 2025, THE PRODUCT WITH LOT NUMBER 5925648 WAS RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.
D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. SECTION D6B: EXPLANTATION DATE: (B)(6) 2024. 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: MATERIAL RUPTURE. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
ON JULY 22, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT IT WAS THE LEFT BREAST IMPLANT THAT DEFLATED, 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501660 LOT: 5925648. THE SUSPECT MEDICAL DEVICE WAS UPDATED AND A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THIS DEVICE WAS RETURNED ON FEBRUARY 18, 2025. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
ON SEPTEMBER 29, 2025, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND A CREASE WAS NOTED ON THE ANTERIOR VIEW. IN ADDITION, A TEAR WAS NOTED WITHIN THE CREASE MEASURING APPROXIMATELY 0.2 CM. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A DEFLATION IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA, AND THAT NORMAL WEAR MAY HAVE CAUSED THE OBSERVED DEFECT. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO UNKNOWN MENTOR SMOOTH SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49329 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5925648 | 00081317001270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |