BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER SINGLE INNER SETSCW

    MDR report key: 3203028 · Received July 2, 2013

    Report

    Report Number
    1526439-2013-20413
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES EXAMINATION OF THE FOUR CONCOMITANT DEVICE SET SCREWS THAT WERE ALSO RETURNED FOUND NO DEFECTS OR ANOMALIES.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED SET SCREW FOUND ITS THREADS WERE TORN. REVIEW OF THE DEVICE HISTORY FOR THIS PRODUCT LOT FOUND NO DISCREPANCIES. A TWELVE MONTH COMPLAINT TREND ANALYSIS FOUND NO SIGNIFICANT TRENDS. ALTHOUGH THE ROOT CAUSE OF THE THREAD TEARING CANNOT POSITIVELY BE POSITIVELY DETERMINE, THE DAMAGE APPEARS TO BE RELATED TO INADVERTENT CROSS-THREADING DURING ATTEMPTED INSERTION. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE AND THERE HAVE BEEN NO SYSTEMATIC TRENDS. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS WHEN ATTEMPTING TO TIGHTEN THE VIPER SINGLE INNER SET SCREW, THE DEVICE ENTERED INTO THE PEDICLE SCREW HEAD AT AN ANGLE WHICH RESULTED IN POOR POSITIONING OF THE SET SCREW. AS THE SET SCREW WAS REMOVED, THREADS WERE TORN FROM THE DEVICE. THE SURGEON HAD DIFFICULTY ASSEMBLING TEN ADDITIONAL VIPER SINGLE INNER SET SCREWS AND, AS A RESULT, CHANGED FROM A MINIMALLY INVASIVE TO AN OPEN PROCEDURE. AS A RESULT OF THE SET SCREW ASSEMBLY DIFFICULTIES, THE PROCEDURE WAS EXTENDED BY TWO HOURS AND PROCEDURES THAT HAD BEEN SCHEDULED FOR LATER IN THE DAY HAD TO BE SUSPENDED. THE PATIENT OUTCOME WAS REPORTED TO HAVE BEEN GOOD ALTHOUGH THE DIFFICULTY IS REPORTED TO HAVE RESULTED IN MUCH BLEEDING. CONCOMITANT DEVICES: ADDITIONAL VIPER SINGLE INNER SET SCREWS, 186715000, QUANTITY = 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301094 VIPER SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APCBBT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) X 4