BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORETECH ROM KNEE IMOBILIZER

    MDR report key: 23553689 · Received November 14, 2025

    Report

    Report Number
    23553689
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 20, 2025
    Manufacturer
    VIVE HEALTH LLC
    Product Code
    ITQ
    UDI-DI
    00810041986108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT STANDING IN PARALLEL BARS IN R [RIGHT] HINGED KNEE IMMOBILIZER (WBAT) AND NWB [NON WEIGHT BEARING] ON L LE [LEFT LOWER EXTREMITY] IN IMMOBILIZER (NON-HINGED), PERFORMING 3RD REP OF L HIP FLEXION WITH WHEELCHAIR BEHIND PATIENT, WHILE STANDING ON R LE [RIGHT LOWER EXTREMITY] AND R KNEE BUCKLED WHILE BRACE WAS STILL LOCKED IN EXTENSION. PATIENT SUPPORTED SELF ON PARALLEL BARS AND THERAPIST ASSISTED TO PREVENT FALL WHILE 2ND THERAPIST ASSISTED IN MOVING WHEELCHAIR UNDER PATIENT'S BUTTOCKS. UPON INSPECTION OF THE BRACE, BRACE STILL LOCKED IN EXTENSION, BUT SUPPORT BARS WERE TWISTED. ALERTED MD AND RN. RN PRESENT TO ASSESS PATIENT. PAIN REPORTS AT R KNEE OF 2/10. STAT IMAGING ORDERED BY MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902780 CORETECH ROM KNEE IMOBILIZER JOINT, KNEE, EXTERNAL BRACE ITQ VIVE HEALTH LLC SUP2071BLK 00810041986108

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| H