BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 8086183 · Received November 19, 2018

    Report

    Report Number
    1645337-2018-06884
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002017
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. DURING INITIAL EVALUATION THE DEVICE APPEARED INTACT. LEAK TESTING OF THE DEVICE, IN ACCORDANCE WITH MENTOR PROCEDURES, REVEALED A RENT ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.2 CM. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. NO OTHER ANOMALIES WERE OBSERVED. COMPLAINT WAS CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND IN THE DEVICE. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS. THIS TYPE OF STRIATIONS IS MORE CONCLUSIVE TO SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. 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. (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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. CONCOMITANT MEDICAL PRODUCTS: RIGHT -MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE BREAST IMPLANT, LOT NUMBER 230362, CATALOG NUMBER 3501470. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE SPONTANEOUSLY DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLACED WITH SERIAL NUMBER (B)(4), CATALOG NUMBER SHPX465 AND RIGHT REPLACED WITH SERIAL NUMBER (B)(4), CATALOG NUMBER SHPX490 ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925638 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 226524 00081317002017

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention