BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER 2 X-TAB CANNULATED SCREW 6X50MM TI 2810

    MDR report key: 2820711 · Received November 6, 2012

    Report

    Report Number
    1526439-2012-00252
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 19, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NKB
    PMA / PMN Number
    K041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAGNIFIED VISUAL OF THE RETURNED SCREW FOUND INDICATIONS OF METAL DEFORMATION ON THE TOP SIDE OF THE SCREW'S INNER SADDLE. METAL DEFORMATION WAS ALSO NOTED AROUND HEX LOBE PROFILE. THE DAMAGE SUGGESTS THAT THE TIP OF A DRIVER USED TO REMOVE THE SCREW MAY HAVE NOT BEEN SEATED FULLY WITHIN THE SCREW'S HEXLOBE FEATURE. THIS MAY HAVE CAUSED DAMAGE TO THE DRIVER WHICH RESULTED IN A CIRCUMSTANCE THAT PUT SUBSTANTIAL SIDE LOADING ON THE SADDLE, CAUSING IT TO BECOME DISLODGED. THE PREVIOUS AND CURRENT CONDITION OF THE DRIVER TIP IS UNKNOWN. HOWEVER, NO DEFINITIVE CONCLUSIONS CAN BE MADE. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    THE SCREW HAS BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT REVISION SURGERY WAS PERFORMED DUE TO SCREW LOOSENING. REPORTS IT IS NOT KNOWN IF SCREW LOOSENING WAS DUE TO PSEUDOARTHROSIS OR IF PSEUDOARTHROSIS WAS DUE TO SCREW LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER 2 X-TAB CANNULATED SCREW 6X50MM TI 2810 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY RAYNHAM T7026

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention