BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P IMPLANT

    MDR report key: 2559708 · Received April 19, 2012

    Report

    Report Number
    1719045-2012-00350
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Report Date
    March 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A YOUNG AND HEALTHY PT WAS IMPLANTED WITH A ZERO-P IMPLANT (PLATE AND SCREWS) AT C5-6 IN (B)(6) 2010. F/U X-RAYS SHOWED THAT ONE OF THE SCREWS HAD BACKED OUT AT C6. PT IS ASYMPTOMATIC AND PRESENTLY, SURGEON HAS NO PLANS FOR REVISION. THIS IS THE 2ND OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO-P IMPLANT ZERO-P IMPLANT ODP SYNTHES MONUMENT 3406306

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR SCREWS