BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIST SPANNING PLATE, TI

    MDR report key: 9519702 · Received December 26, 2019

    Report

    Report Number
    1220246-2019-01541
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867183674
    PMA / PMN Number
    K143749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD TO REMOVE THE WRIST SPANNING PLATE, AR-8916SPN, BECAUSE THE SCREWS WERE NOT LOCKED INTO THE DISTAL HOLES. NO FURTHER INFORMATION, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 12/18/19: CASE DATE OF IMPLANTATION: 7/11/2019, CASE DATE OF EXPLANTATION: NOT YET DETERMINED. THE FOLLOWING SCREWS WERE ALSO EXPLANTED DURING THE REVISION: AR-8724-10 LOT: 1058931, AR-8724V-10 LOT: W654331, AR-8724V-16 LOT: W630941, AR-8935-12 LOT: 10220124, AR-8935L-12 LOT: 10248943, AR-8935L-12 LOT: 10257929. (DATE OF EXPLANTING PROCEDURE UNKNOWN. (B)(6) 2019 DATE OF REPORT TO ARTHREX HAS BEEN ENTERED AS DATE OF EVENT/EXPLANT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312643 WRIST SPANNING PLATE, TI PLATE, FIXATION, BONE HRS ARTHREX, INC. WRIST SPANNING PLATE, TI 00888867183674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other