BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8647436 · Received May 28, 2019

    Report

    Report Number
    1645337-2019-12726
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    February 28, 2019
    Report Date
    May 6, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000716
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7/3/2019, DURING ANALYSIS OF THE SAMPLE AN AREA OF SILTEX CRACKING WAS NOTED IN THE POSTERIOR VIEW. WITHIN SILTEX CRACKING AND AREA OF MISSED MATERIAL WAS NOTED, MEASURING APPROXIMATELY 1.0 CM X 0.3 CM . 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 223365, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES CAUSED BY ACUTE FOLDS (I.E., SEVERE ¿V¿ OR TIGHT FOLDS) IN THE HTV ( HIGH TEMPERATURE VULCANIZATION) SHELL OF SILTEX BREAST IMPLANTS. RUPTURE 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. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE CONCOMITANT PRODUCTS: A GEL MENTOR MEMORYGEL BREAST IMPLANT 400CC , CATALOG NUMBER :3544007, LOT: 223365, SERIAL NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A GEL MENTOR MEMORYGEL BREAST IMPLANT 400CC AND EXPERIENCED RIGHT SIDE RUPTURE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR SILICONE BREAST IMPLANT OF UNKNOWN TYPE ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440714 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 223365 00081317000716

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention