BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MOD. PROFILE

    MDR report key: 8618239 · Received May 16, 2019

    Report

    Report Number
    1645337-2019-12091
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    May 11, 2018
    Report Date
    April 29, 2019
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317006633
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 05/23/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: - THE MENTOR FAILURE ANALYSIS LAB 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. - IT WAS INITIALLY REPORTED THAT THE SUSPECT MEDICAL DEVICE IS A DEVICE, CATALOG #3548316. NEW INFORMATION STATES THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR SILTEX ROUND MOD. PROFILE 350CC GEL BREAST PROSTHESIS, CATALOG #354-3257, LOT #1003743. THIS DEVICE WAS MANUFACTURED IN MENTOR¿S FACILITY IN (B)(4). ON 06/04/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, 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 CONTACT PHONE NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 07/10/2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED A RUPTURE ON THE BREAST IMPLANT. DURING THE EVALUATION OF THE SAMPLE, IT WAS NOTICED THAT TWO LINES OF SHELL WEAR WERE OBSERVED ON THE ANTERIOR ASPECT RUNNING TO THE POSTERIOR ASPECT, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. IN ADDITION, A RUPTURE IN THE POSTERIOR ASPECT WAS OBSERVED MEASURING 1.5 CM WITHIN THE SHELL WEAR. NO ADDITIONAL ANOMALIES WERE OBSERVED. A FOLD OR WRINKLE RUPTURE IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF MAMMARY PROSTHESES. AS STATED IN THE PRODUCT INSERT DATA SHEET, CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN RUPTURE IN A LATER TIME. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE REPORTED COMPLAINT WAS CONFIRMED. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION OF LEFT BREAST TISSUE EXPANDER. 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 PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 750CC DEVICE THE DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT SIDE DEVICE WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409764 MENTOR SILTEX ROUND MOD. PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 1003743 00081317006633

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention