BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDS PLATING SYSYEM

    MDR report key: 12572501 · Received October 4, 2021

    Report

    Report Number
    3009222247-2021-00012
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 17, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BIEDERMANN MOTECH, INC.
    Product Code
    HRS
    UDI-DI
    10812269023556
    PMA / PMN Number
    K172786
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA E-MAIL ON (B)(6) 2021 THAT A REVISION SURGERY WAS NEEDED TO REMOVE A BROKEN 10 HOLE NARROW PLATE. THE PLATE WAS BROKEN IN HALF AND SAFELY REMOVED FROM THE PATIENT. ON (B)(6) 2021 THE REPORTER STATED VIA PHONE CALL THAT THE PATIENT REPORTED SHE WOKE UP IN PAIN AS IF HER ARM WAS BROKEN. WHEN SHE GOT TO THE HOSPITAL IT WAS DISCOVERED THAT THE PLATE WAS BROKEN IN HALF. THERE ARE NO IMAGES OF THE EVENT. IT WAS DESCRIBED THE BROKEN PLATE WAS NOT PRE BENT AND WAS LOCATED BELOW THE SURGICAL NECK OF THE HUMERUS, BETWEEN THE OLECRANON. THE PLATE AND SCREWS WERE REMOVED WITH NO ISSUES. THERE ARE NO REPORTS OF DELAYS OR IMPACT ON THE PATIENTS OUTCOME AS A RESULT OF THE REVISION SURGERY. SUBJECT ITEMS WILL NOT BE RETURNED. THE REVISION SURGERY INCLUDED REMOVING THE BROKEN PLATE AND REPLACING IT WITH 2 3.5T NARROW PLATES, A 8 HOLE NARROW PLATE AND 10 HOLE NARROW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467870 MDS PLATING SYSYEM NARROW PLATE, 3.5T, 10 HOLE HRS BIEDERMANN MOTECH, INC. MDS1101N10 INFROMATION NOT AVAILABLE 10812269023556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention