BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER2 STRAIGHT ROD480MM, COCR

    MDR report key: 2881913 · Received December 20, 2012

    Report

    Report Number
    1526439-2012-84002
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 18, 2012
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK090648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPINAL ROD IS NOT AVAILABLE FOR EVALUATION. TWO CONCOMITANT DEVICE TORQUE WRENCH HANDLES ONLY WERE RETURNED FOR EVALUATION. THE INSTRUMENTS, MANUFACTURED IN APRIL 2004 AND NOVEMBER 2006, WERE HEAVILY BASED UPON THE NUMEROUS MARKINGS ON THE HARD COAT ANODIZED SURFACES AND BENT SETTING PINS. TORQUE TESTING FOUND BOTH INSTRUMENTS APPLIED TORQUE EITHER AT THEIR REQUIRED SPECIFICATION VALUE OR ABOVE, SUGGESTING THAT THE CONCOMITANT DEVICE SET SCREW WAS NOT UNDER TORQUE. REVIEWS OF THE DEVICE HISTORY RECORDS FOUND THE TORQUE WRENCH HANDLE PRODUCTION LOTS MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. THE CAUSE OF THE SPINAL ROD SLIPPAGE CANNOT BE DETERMINED. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES SPINE HAS REQUESTED RETURN OF THE ROD FOR EVALUATION. HOWEVER, IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE OR IF IT IS DETERMINED THAT THE ROD IS NOT AVAILABLE FOR EVALUATION. REQUESTED. NOT KNOWN IF AVAILABLE.

    Description of Event or Problem · 1

    THE LEFT SIDE LOWER L4 ROD SLIPPED OUT OF SCREW HEAD WITH SET SCREW STILL INTACT. ROD SLIPPAGE RESULTED IN THE NEED FOR REVISION SURGERY. DEPUY SYNTHES SPINE BECAME AWARE OF THE EVENT ON (B)(4) 2012. THE SALES REPRESENTATIVE HAS BEEN REMINDED OF THE NEED TO IMMEDIATELY REPORT ADVERSE EVENTS. CONCOMITANT DEVICES: EXPEDIUM SI SET SCREW, 179702000; EXPEDIUM SI POLYAXIAL SCREW, CATALOG# UNKNOWN; TORQUE WRENCH HANDLES, 277040510

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER2 STRAIGHT ROD480MM, COCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention