BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 2945264 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10029
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING¿ THE SAMPLE WAS NOT RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION L2-PELVIS PROCEDURE, THE SURGEON ROUNDED OFF THE TIPS OF THREE T-25 STARDRIVE SHAFTS. THE ROD TIPS OF THE ROD CUTTER WERE BROKEN AND THE SURGEON CUT THE ROD. ALL PIECES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED WITH NO EFFECT TO THE PT. THIS COMPLAINT IS ON A T-25 STARDRIVE SHAFT. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44879 ROD CUTTER HXZ SYNTHES TUTTLINGEN T959010

    Patients

    Seq Age Sex Outcome Treatment
    1 T25 STARDRIVE SHAFT F/MATRIS X3