BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX DX REINFORCED MATRIX

    MDR report key: 9240625 · Received October 25, 2019

    Report

    Report Number
    2530154-2019-00007
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    DSM BIOMEDICAL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY FILES FOR FINAL PRODUCT LOT 7002099 AND INTERMEDIATE MATERIAL LOTS 8002159 (PN 6445-61) AND E8176 (PN 6199-04) SHOW NO NCR THAT COULD CAUSE FAILURE MODE. DEVICE COULD NOT BE RETURNED. ROOT CAUSE COULD NOT BE DETERMINED AND DHF REVIEW SHOWS NO NCR/DEVIATION FROM PROCESS THAT COULD LEAD TO FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTHREX DX DEVICE (ABS-30002) WAS IMPLANTED. AFTER 6 WEEKS, A SYNOVIALITIS DEVELOPED IN THE PATIENT. A REVISION SURGERY TO AN INVERSE PROTHESIS WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035104 ARTHREX DX REINFORCED MATRIX SURGICAL MESH FTM DSM BIOMEDICAL, INC. 30031-02 7002099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention