BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 20018838 · Received August 21, 2024

    Report

    Report Number
    1645337-2024-09763
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 16, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317007135
    PMA / PMN Number
    P030053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 24, 2024, THE MENTOR ANALYSIS LAB RECEIVED TWO DEVICES FOR EVALUATION. ON SEPTEMBER 30, 2024, MENTOR COMPLETED EVALUATIONS ON THE RETURNED DEVICES. THE IDENTITY OF THE RUPTURED SUSPECT MEDICAL DEVICE WAS DETERMINED AS THE FOLLOWING: LOT: 9950540. SERIAL: (B)(6). MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BREAST IMPLANT WAS FOUND TO BE RUPTURED. MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: ACCORDING TO THE PRODUCT INSERT DATA SHEET, IT IS POSSIBLE TO DAMAGE THE IMPLANT DURING INSERTION. ENSURE THAT EXCESSIVE FORCE IS NOT APPLIED TO A VERY SMALL AREA OF THE SHELL DURING INSERTION OF THE DEVICE THROUGH THE INCISION. INSTEAD, APPLY FORCE OVER AS LARGE AN AREA OF THE IMPLANT AS POSSIBLE. AVOID PUSHING THE DEVICE INTO PLACE WITH ONE OR TWO FINGERS IN A LOCALIZED AREA, AS THIS MAY CREATE AN AREA OF WEAKNESS ON THE SHELL. IN ADDITION, AN INCISION SHOULD BE OF APPROPRIATE LENGTH TO ACCOMMODATE THE STYLE, SIZE, AND PROFILE OF THE IMPLANT. THIS WILL REDUCE THE POTENTIAL FOR CREATING EXCESSIVE STRESS TO THE IMPLANT DURING INSERTION, AND WILL AVOID THE RISK OF DAMAGE TO THE IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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 (MRE) WAS PERFORMED FOR LOTS 9950540 AND 9984734, 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: FULL UDI CURRENTLY UNAVAILABLE SINCE THE EXACT LOT OF THE SUSPECTED DEVICE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 375CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS RUPTURED DURING A BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED. AS THE AFFECTED DEVICE WAS NOT PROVIDED, THE LOT/SERIAL NUMBERS FOR BOTH PRODUCTS ARE BEING PROVIDED AS DEVICE A - LOT NUMBER: 9950540 / SERIAL NUMBER: (B)(6) AND DEVICE B - LOT NUMBER: 9984734 / SERIAL NUMBER: (B)(6). FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179206 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9950540 00081317007135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown