BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTIUSE SCREW, Ø3.5MM X L42MM

    MDR report key: 6669858 · Received June 27, 2017

    Report

    Report Number
    3009222247-2017-00006
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 20, 2017
    Report Date
    June 20, 2017
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HWC
    PMA / PMN Number
    K141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE REPORT NUMBER FOR MEDICAL DEVICES INVOLVED IN THE SAME EVENT DESCRIBED IN THIS SUBMISSION 3009222247-2017-00005. PRIMARY DI NUMBER: (B)(4). INVESTIGATION: THE DEVICE ASSOCIATED WITH THIS MDR WAS NOT RETURNED, THEREFORE THE DEVICE COULD NOT BE INSPECTED AND THE LOT NUMBER IS NOT AVAILABLE FOR A REVIEW OF THE DHR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT REVISION SURGERY WAS CONDUCTED FOR A MIAMI DEVICE SOLUTIONS (MDS) PROXIMAL HUMERUS PLATING SYSTEM IMPLANTED ON (B)(6)2017. NO COMPLICATIONS WERE REPORTED DURING THE INITIAL IMPLANTATION PROCEDURE. MDS WAS INFORMED ON (B)(6)2017 THAT REVISION SURGERY WAS CONDUCTED THE SAME DAY. BASED ON SURGEON FEEDBACK THREE OF THE SCREWS WERE PROTRUDING INTO THE JOINT SPACE. THEY WERE REMOVED AND REPLACED WITH SHORTER MDS SCREWS. NO COMPLICATIONS WERE REPORTED DURING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451434 MULTIUSE SCREW, Ø3.5MM X L42MM 3.5MM MULTIUSE SCREW HWC MIAMI DEVICE SOLUTIONS LLC MDS1102M42

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention