BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P IMPLANT 8MM HEIGHT

    MDR report key: 2142970 · Received June 21, 2011

    Report

    Report Number
    1719045-2011-00306
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 2, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE NOT EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST ZERO-P PLATE AND SCREW IMPLANTATION IN (B)(6) 2010 RETURNED TO SURGEON FOR ONE YEAR CHECK UP AND WAS ASYMPTOMATIC. X-RAYS TAKEN SHOWED TWO SCREWS WERE BROKEN IN THE PLATE WITH SURGEON NOTING FUSION HAD OCCURRED. SURGEON IS NOT REMOVING THE HARDWARE AND IS MONITORING THE PATIENT. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P IMPLANT 8MM HEIGHT ZERO-P IMPLANT KWQ SYNTHES MONUMENT NA 3273479

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW