BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNESYS STABILIZATION SYSTEM

    MDR report key: 1031915 · Received April 16, 2008

    Report

    Report Number
    2184052-2008-00013
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - NO DEVICE HISTORY RECORD DISCREPANCIES. INSTRUMENT WAS MFG TO ALL APPLICABLE SPECS AND REQUIREMENTS.

    Description of Event or Problem · 1

    SURGERY DATE WAS 2008, TO REMOVE ANOTHER MANUFACTURER'S PEDICLE SCREW SYSTEM AT L3/4 (FUSED) AND INSERT DYNESYS FROM L2 TO S1. AT L4 LEFT SIDE A 6.0X45MM SCREW WAS REMOVED. A 6.4X50MM DYNESYS PEDICLE SCREW WAS INSERTED INTO THE SAME SCREW HOLE AT L4. DURING INSERTION THE DISTAL END OF THE PEDICLE SCREW DRIVER FRACTURED. PT REPORTED TO HAVE VERY HARD BONE. THE FRACTURED PIECE WAS REMOVED FROM THE WOUND AND DISPOSED OF AT THE HOSP. THE SECOND PEDICLE SCREW DRIVER AVAILABLE IN THE INSTRUMENT TRAY WAS USED TO SUCCESSFULLY IMPLANT THE REMAINING SCREWS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS STABILIZATION SYSTEM PEDICLE SCREW DRIVER NQP ZIMMER SPINE, INC. 07.00770.002 P042372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other