BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8340330 · Received February 14, 2019

    Report

    Report Number
    1645337-2019-08575
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 17, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2/14/2018, UPON RECEIVE OF THE SUSPECT DEVICE THE DEVICE IDENTIFIED WITH CATALOG NUMBER 3542645, LOT NUMBER 5973454. A MANUFACTURING RECORD EVALUATION (MRE) REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE LEFT DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 1.6 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED PARALLEL STRIATIONS. NO OTHER ANOMALIES WERE DISCOVERED. 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. AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE YELLOW MATERIAL FOUND ON THE DEVICE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 5973454 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION (DHR) REVIEW COULD BE PERFORMED. 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 A SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT AND LOSS OF VOLUME WITH RIPPLING ON THE RIGHT BREAST IMPLANT. THE PATIENT EXPLAINED, BREASTS FEEL LIKE POPPING. AS A RESULT THE PATIENT UNDERWENT REMOVAL OF THE IMPLANTS ON (B)(6) 2019. THIS IS FOR THE LEFT SIDE IMPLANT; SEE MANUFACTURER REPORT NUMBER 1645337-2019-08576 FOR CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134021 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5973454

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention