BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3814886 · Received May 1, 2014

    Report

    Report Number
    3814886
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZIMMER SPINE, INC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PUTTING THE ZIMMER SPINE RETRACTOR TOGETHER ON THE FIELD, A BLACK PIECE BROKE OFF, NOT WAND SITE. THIS DID NOT HAPPEN ON THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261934 * INSTRUMENT, SURGICAL, MANUAL MAX ZIMMER SPINE, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR