BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE SPECTRUM

    MDR report key: 8264446 · Received January 21, 2019

    Report

    Report Number
    1645337-2019-08017
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    December 31, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002178
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2/20/19, DEVICE EVALUATION AND INVESTIGATION FINDINGS: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.4 CM WITHIN A LINE OF SHELL WEAR, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 5934738 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. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. 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. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR SILTEX CONTOUR PROFILE SPECTRUM 650CC AND EXPERIENCED DEFLATION OF THE LEFT BREAST TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57459 MENTOR SILTEX CONTOUR PROFILE SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5934738 00081317002178

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention