BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER

    MDR report key: 2913928 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00233
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 21, 2009
    Report Date
    December 23, 2009
    Manufacturer
    SYNTHES
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS EXEMPT. 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 IMPLANT WAS TAKEN WITH THE IMPLANT HOLDER FOR SYNEX, FOR POSITIONING THE SYNEX I BODY. SUDDENLY THE BOLT OF THE HOLDER BROKE OFF AND FELL INTO THE PATIENT. THE BOLT WAS LOCATED ON X-RAY EXAMINATION AND THEN DRIED TO REMOVE BY WASHING AND SUCTION CLEANING. FURTHER X-RAY CHECKING DID NOT SHOW THE PART IN THE PATIENT ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19927 IMPLANT HOLDER FZX SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1