BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P IMPLANT 6MM HEIGHT CONVEX-STERILE

    MDR report key: 2954492 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-00852
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 13, 2009
    Report Date
    November 23, 2009
    Manufacturer
    SYNTHES
    Product Code
    ODP
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED THE IMPLANT SEPERATED FROM THE PLATE WHILE HAMMERING. THE TITANIUM PART CAME APART FROM THE PEEK PART AFTER THE FIRST HIT WITH A HAMMER DURING THE INSERTION. THE SURGEON USED A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58561 ZERO-P IMPLANT 6MM HEIGHT CONVEX-STERILE ZERO-P IMPLANT 6MM HEIGHT ODP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1