BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM

    MDR report key: 13322318 · Received January 21, 2022

    Report

    Report Number
    2031009-2022-00001
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    December 5, 2021
    Report Date
    January 21, 2022
    Manufacturer
    TRIMED INC
    Product Code
    HRS
    UDI-DI
    00842188101458
    PMA / PMN Number
    K060041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A TRIMED DISTRIBUTOR FROM (B)(6), NOTIFIED TRIMED ON 05 DEC 2021 THAT A SWOR-7M HAD BROKEN AND NEEDED TO BE REMOVED FROM THE PATIENT. THE DATE BELIEVED TO BE THE DATE OF REMOVAL WAS (B)(6) 2021. IT IS CURRENTLY BELIEVED THAT THE BREAK IN THE PLATE WAS CAUSED BY A NONUNION, HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE YET. THIS DEVICE WAS IMPLANTED FOR APPROXIMATELY 3 MONTHS BEFORE THE BREAK WAS DETECTED IN AN X-RAY WHICH PROMPTED THE REMOVAL OF THE DEVICE. IT IS CURRENTLY BELIEVED THAT THE PATIENT HAS SINCE STARTED HEALING WELL, HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE YET. ADDITIONAL INFORMATION WAS REQUESTED ON THE FOLLOWING DATES, 06 DEC 2021, 09 DEC 2021, 14 DEC 2021, 16 DEC 2021, 28 DEC 2021 AND 03 JAN 2022, WITH NO ADDITIONAL INFORMATION PROVIDED AS OF 04 JAN 2022.

    Description of Event or Problem · 0

    A TRIMED DISTRIBUTOR FROM (B)(6) MEDICAL LOCATED IN CHINA, NOTIFIED TRIMED ON (B)(6) 2022 THAT THE PLATE HAD NOT BROKEN DUE TO A NONUNION BUT MORE LIKELY THE PLATE BROKE DUE TO THE PATIENT NOT FOLLOWING THE CORRECT AFTER CARE INSTRUCTIONS. IT WAS DETERMINED THAT THE PATIENT HAD BEEN PARTICIPATING IN SPORTS WHICH CAUSED THE PATIENT TO FALL AND RE-BREAK THE PLATE AND BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661203 SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM HRS TRIMED INC SWOR-7M MX20007 00842188101458

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention