BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 321586 · Received March 19, 2001

    Report

    Report Number
    MW1021374
    Event Type
    Malfunction
    Date Received
    March 19, 2001
    Date of Event
    February 28, 2001
    Report Date
    March 5, 2001
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WAS PULLING UP WITH TRAPEZE BAR WHEN THE TRAPEZE FRAME BRACKET BROKE AND STRUCK PT IN THE HEAD CAUSING A RAISED AREA. ALTHOUGH THE PT'S BACK WAS NOT INJURED, THERE WAS A POTENTIAL FOR HARM DUE TO DIAGNOSIS OF LUMBAR DISC HERNIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12041 ZIMMER Z-SWING CLAMP - TRAPEZE FRAME BRACKET HSQ ZIMMER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other