BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 2915684 · Received January 15, 2013

    Report

    Report Number
    2520274-2013-00341
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 17, 2009
    Report Date
    February 2, 2009
    Manufacturer
    SYNTHES
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS EXEMPT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 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

    (B)(6) REPORTED AN EXTRACTION SCREW BROKE DURING THE REMOVAL OF THE LESS INVASIVE STABILIZATION SYSTEM PLATE. THE SCREWS WERE IMPLANTED USING A TORQUE LIMITING ATTACHMENT, BUT THERE WAS STILL A PROBLEM REMOVING THEM. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22230 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS CONICAL EXTRACTION SCREW HWB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention