BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II POLYAX SCRHOLDER3

    MDR report key: 3151399 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02838
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    October 13, 2011
    Report Date
    October 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INVESTIGATION REPORT INDICATES THAT THE GUIDING SHAFT WAS BROKEN AS COMPLAINED. THE SPIRAL FRACTURE BEHAVIOR INDICATES THAT HIGH TORSIONAL LOADS WERE APPLIED. THE PRESENT INSTRUMENT IS WITHIN COMPLIANCE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE PRESENT SCREW HOLDER WAS MANUFACTURED WITHIN ACCORDANCE TO ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DEVICE, POLYAXIAL HEAD HOLDER, GUIDING SHAFT BROKE DURING AN IMPLANT REMOVAL SURGERY. THE SCREW HOLDER WAS MOUNTED ON THE 3 DIMENSIONAL HEAD. WHILE THE SURGEON WAS USING A WRENCH AND THE COUNT TORQUE INSTRUMENT DURING A NUT REMOVAL, THE SCREW HOLDER BROKE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253366 USS-II POLYAX SCRHOLDER3 LXH SYNTHES GMBH 1392094

    Patients

    Seq Age Sex Outcome Treatment
    1