BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBX NON-BRIDGING EXTERNAL FIXATOR - SHOULDER

    MDR report key: 1487842 · Received September 29, 2009

    Report

    Report Number
    3005893246-2009-00001
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    September 22, 2009
    Report Date
    September 28, 2009
    Manufacturer
    NUTEK ORTHOPAEDICS, INC.
    Product Code
    KTT
    PMA / PMN Number
    K082833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE INFORMED THAT THE PHYSICIAN ADMITTED THE PT TO THE HOSPITAL REINFORCING HER ACTIVITY RESTRICTIONS. SHE WILL ALSO UNDERGO ADDITIONAL TRAINING REGARDING NON-WEIGHT BEARING. WE WERE INFORMED BY THE PHYSICIAN THAT THIS EVENT OCCURRED DUE TO THE PT PUTTING HER WEIGHT ON THE AFFECTED LIMB WHILE TRYING TO GET OUT OF BED SOON AFTER APPLICATION OF THE DEVICE. THE INSTRUCTIONS FOR USE CLEARLY STATE UNDER WARNINGS, FACTORS SUCH AS THE PT'S WEIGHT, ACTIVITY LEVEL, AND ADHERENCE TO WEIGHT BEARING OR LOAD BEARING INSTRUCTION HAVE AN EFFECT ON THE SERVICE LIFE OF THE DEVICE.

    Description of Event or Problem · 1

    APPROXIMATELY ONE WEEK AFTER APPLICATION OF THE DEVICE (NBX SHOULDER FIXATOR), PT PUT HER ENTIRE WEIGHT ON THE AFFECTED EXTREMITY TO PUSH HERSELF OUT OF BED, DISLOCATING THE FIXATOR AND LOOSING REDUCTION. IN 2009, THE PHYSICIAN AGAIN TOOK PT INTO SURGERY TO RE-ALIGN THE ANATOMICAL COMPONENTS (REDUCE THE FRACTURE), AND RE-ATTACH THE FIXATOR. THE PT WILL BE KEPT IN THE HOSPITAL FOR AN UNK AMOUNT OF TIME TO REINFORCE HER ACTIVITY RESTRICTIONS. THE PHYSICIAN STATED THAT THE PT'S WEIGHT WAS A CONTRIBUTING FACTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBX NON-BRIDGING EXTERNAL FIXATOR - SHOULDER NBX SHOULDER KTT NUTEK ORTHOPAEDICS, INC. NP07212009

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention