BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOCKER

    MDR report key: 4223500 · Received October 29, 2014

    Report

    Report Number
    3003853072-2014-00034
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SAME COMPLAINT AS: 3003853072-2014-00033. THE DEVICE WAS IMPLANTED ON (B)(6) 2014. IN (B)(6), PATIENT COMPLAINED ON PAIN. X-RAY SHOWED BLOCKER LOOSENING. THE BLOCKER WAS EXPLANTED ON (B)(6) AND REPLACED BY THE OTHER PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 06OCT2014. X-RAY SHOWED TWO BLOCKERS WERE OUT OF THE SCREWS HEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692725 BLOCKER BLOCKER NKB ZIMMER SPINE 046W0AN00002 V13003289

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention