BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 17605236 · Received August 22, 2023

    Report

    Report Number
    MW5144877
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 10, 2023
    Report Date
    August 21, 2023
    Manufacturer
    SKELETAL DYNAMICS, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGEON WAS REMOVING SKELETAL DYNAMICS PLATE FROM A WRIST ON (B)(6) 2023. SURGEON ATTEMPTED TO USE OUR SCREW REMOVAL SET TO REMOVE THE PLATE. AT SOME POINT, A SMALL CRUCIFORM SCREW BROKE WHILE TRYING TO REMOVE A SCREW. THE PLATE HAD TO BE CUT WITH A BURR ALSO BECAUSE THE SURGEON DID NOT HAVE THE PROPER EQUIPMENT FROM SKELETAL DYNAMICS TO REMOVE THEIR PLATE. THIS COMPLAINT INVOLVES TWO(2) DEVICES. REFERENCE REPORT: MW5144876. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286425 PLATE, FIXATION, BONE PLATE, FIXATION, BONE HRS SKELETAL DYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STRYKER WRIST FUSION SYSTEM