MENTOR SILTEX ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-02831
- Event Type
- Injury
- Date Received
- May 11, 2018
- Date of Event
- April 12, 2018
- Report Date
- April 24, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
ON 8/30/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: EXPLANTATION DATE: 8/24/2018 IS OTHER SERIOUS: UNCHECK IS REQUIRED INTERVENTION: CHECK METHOD CODES: 4114 RESULT CODES: 3221 ALSO ON 8/30/2018, MENTOR BECAME AWARE THAT INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN DEVICE WAS RECEIVED AND MISTAKENLY OMMITTED: BRAND NAME: MENTOR SILTEX ROUND MODERATE PROFILE, PROCODE: FWM, COMMON DEVICE NAME: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE, CATALOG: 3542635, LOT: 6861915, SERIAL: (B)(4), UNIQUE IDENTIFIER (UDI): (B)(4), PMA/ 510(K): P990075, DATE RECEIVED BY MANUFACTURER: 9/9/2014. IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 270CC GEL PROSTHESES ON (B)(6) 2018; CATALOG # SMPX270, S/NS (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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 2/12/2019, MENTOR BECAME AWARE THAT THE INCORRECT LOT NUMBER WAS REPORTED FOR THE SUSPECT MEDICAL DEVICE. THE CORRECT LOT NUMBER IS 7323665. THE CORRECT CONCOMITANT DEVICE WAS ALSO A 250CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE CATALOG: 6735767 LOT: 7323665. ON 2/25/2019, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 10/3/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 9/7/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 7/1/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION OF THE SAMPLE A TEAR WAS OBSERVED IN THE POSTERIOR VIEW MEASURING 0.2 CM. DURING THE LEAK TESTING NO ADDITIONAL ISSUES WERE DETECTED. MICROSCOPIC EXAMINATION WAS PERFORMED AND NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. POSSIBLE CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA TO THE BREAST. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. 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. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DIAGNOSED POST. PATIENT HAS A PHYSICIAN APPOINTMENT ON (B)(6) 2018 TO CONFIRM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANT DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350905 | MENTOR SILTEX ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 7323665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R | SEE H10 |