BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANT-CER 2 LVL PLATE ASSY, 40MM

    MDR report key: 2013480 · Received February 3, 2011

    Report

    Report Number
    1649384-2011-00017
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT DISCREPANCIES WERE IDENTIFIED WITH THE RETURNED DEVICES. NO EVIDENCE OF TAMPERING WAS EVIDENT AND THE PLATE WAS FUNCTIONAL WHEN REASSEMBLED. THIS APPEARS TO BE AN ISOLATED INCIDENT AND NO CONCLUSION CAN BE MADE. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADD'L ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 40MM PLATE WAS IMPLANTED AND THEN THE SURGEON NOTICED THE TWO MIDDLE SECTIONS OF THE PLATE DID NOT LOOK ATTACHED. THE PLATE WAS REMOVED FROM THE PT AND A 42MM PLATE IMPLANTED USING 4.5MM RESCUE SCREWS. WHEN THE 40MM PLATE WAS PUT ON THE TABLE IT FELL INTO TWO SEPARATE PIECES. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANT-CER 2 LVL PLATE ASSY, 40MM CERVICAL PLATE KWQ ZIMMER SPINE 1707-2040 51DG/53ER

    Patients

    Seq Age Sex Outcome Treatment
    1