BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL HUMERUS PLATE, 3 HOLE RIGHT

    MDR report key: 6412591 · Received March 17, 2017

    Report

    Report Number
    3009222247-2017-00004
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MIAMI DEVICE SOLUTIONS LLC
    Product Code
    HRS
    PMA / PMN Number
    K141493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2016. NO COMPLICATIONS WERE REPORTED DURING THE INITIAL IMPLANTATION PROCEDURE. MDS WAS INFORMED ON 02/17/2017 THAT REVISION SURGERY HAD TAKEN PLACE ON (B)(6) 2017. THE PROCEDURE TO REMOVE THE IMPLANTS WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194643 PROXIMAL HUMERUS PLATE, 3 HOLE RIGHT PROXIMAL HUMERUS PLATE HRS MIAMI DEVICE SOLUTIONS LLC MDS130103R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention