BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER ROD

    MDR report key: 2161921 · Received July 11, 2011

    Report

    Report Number
    1526439-2011-00119
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 8, 2012
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RODS WERE REMOVED AND REINSERTED INTO THE PATIENT AND SECURED IN PLACE. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT CODES ARE UNKNOWN. NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. HOWEVER, FORCES PLACED UPON THE RODS IN SITU MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    COMPLAINT TREND ANALYSIS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS CATALOG NUMBER.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT APPROXIMATELY TWO WEEKS AFTER THE DEVICES WERE IMPLANTED, THE PATIENT REPORTED TO THE SURGEON WITH SEVERE LOW BACK PAIN AND WAS RE-ADMITTED TO THE HOSPITAL. IMAGES REVEALED THAT TWO SPINAL RODS, LOT CODES UNKNOWN, HAD PULLED OUT FROM THE SCREWS. THROUGH AN OPEN PROCEDURE, THE RODS WERE REMOVED AND REINSERTED INTO THE PATIENT AND SECURED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER ROD SPINAL FIXATION DEVICE NKB DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK VIPER CANN POLY SCREW: (B)(4)| VIPER SINGLE-INNER SET: (B)(4)