BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7293188 · Received February 23, 2018

    Report

    Report Number
    1645337-2018-01044
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    September 1, 2017
    Report Date
    January 29, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 05/31/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5822701 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).

    Additional Manufacturer Narrative · 1

    ON 05/31/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT TO MENTOR, THE DEVICE CONTAINED NO FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. VISUAL EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 0.4 CM WITHIN AN AREA OF SILTEX CRACKING ON THE POSTERIOR VIEW. NO OTHER ANOMALIES WERE FOUND. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND SILTEX CRACKING OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ORIGIN OF THE BROWN MATERIAL OBSERVED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5822701 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. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THAT THE RENT AND SILTEX CRACKING OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX SALINE-FILLED DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES CAUSED BY ACUTE FOLDS (I.E., SEVERE ¿V¿ OR TIGHT FOLDS) IN THE RTV SHELL OF SILTEX SALINE MAMMARIES. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 03/02/2018, IT WAS REPORTED THAT 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE (B)(6) PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH A MENTOR BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. THE DEFLATION WAS NOTICED BY PATIENT ON (B)(6) 2017. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT OF THE LEFT BREAST IMPLANT WITH SALINE MENTOR SILTEX ROUND MODERATE PROFILE 250CC, CATALOG 354-2635, BREAST IMPLANT ON (B)(6) 2018 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135507 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5822701 00081317001768

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention