MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2020-00793
- Event Type
- Injury
- Date Received
- January 14, 2020
- Date of Event
- December 20, 2019
- Report Date
- December 27, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001256
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
ON 1/16/2020, THE MENTOR FAILURE ANALYSIS LAB HAS 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 1/31/2020, MENTOR BECAME AWARE THAT THE PATIENT HAD UNDERGONE REPLACEMENT WITH A 325CC MENTOR ROUND SMOOTH MODERATE PROFILE SALINE IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 2/4/2020, THE PRODUCT INVESTIGATION WAS COMPLETED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. 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. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION OF THE DEVICE IT WAS OBSERVED A CREASE IN POSTERIOR VIEW, ADDITIONALLY A TEAR WITHIN THE CREASE WAS NOTED, MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE RUPTURE IS CONSISTENT WITH A CREASE FOLD RUPTURE. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDER-INFLATION OR OVER-INFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET, RESULTING IN A TEAR AT A LATER DATE. IT IS POSSIBLE THE DEFLATION WAS CAUSED BY THE STRESS OCCASIONED TO THE SHELL BY THE MAMMOGRAM, THE CREASE PRESENT ON SHELL CONTRIBUTED TO BE EASIER THE RUPTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
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: DEFLATION, CHEST INJURY. CONCOMITANT PRODUCTS: (RIGHT) 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501650 LOT: 5990424 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED LEFT BREAST IMPLANT DEFLATION POST-OPERATIVELY. THE PATIENT ALSO REPORTED THAT THEY EXPERIENCED TRAUMA CAUSED BY A MAMMOGRAM ON (B)(6) 2019. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50654 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 3501650 | 5990424 | 00081317001256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |