BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL/GENERIC GENERIC

    MDR report key: 3932084 · Received June 20, 2014

    Report

    Report Number
    2184052-2014-00104
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORT RECEIVED VIA LEGAL THAT SCREWS BACKED OUT ALLEGEDLY DUE TO USING TOO SHORT OF SCREW LENGTH FOR THE ANATOMY WHERE THE CONSTRUCT WAS IMPLANTED NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362414 UNIVERSAL/GENERIC GENERIC UNIVERSAL/GENERIC GENERIC HWC ZIMMER SPINE 1000 UNIVERSAL-GEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1