BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM 5.5 PEEK, PRELORDOSED ROD

    MDR report key: 2120181 · Received June 6, 2011

    Report

    Report Number
    1526439-2011-00092
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 11, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NQP
    PMA / PMN Number
    K073562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED ROD FOUND BREAKAGE OCCURRED IN THE SUPERIOR END OF THE DEVICE. PROVIDED IMAGES WERE EXAMINED BUT NO CONCLUSIONS COULD BE MADE. REVIEW OF THE DEVICE HISTORY RECORD FOUND THE LOT MET SPECIFICATION REQUIREMENTS. COMPLAINT TREND ANALYSIS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THESE PRODUCTION LOTS. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS WITH CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    CONTACT REPORTS PATIENT WAS PERFORMING DEEP FLEXION MANEUVER WHILE WORKING IN YARD TWO MONTHS POST-OP AND FELT A "POP" IN HIS LOWER BACK. PATIENT EXPERIENCED WORSENING LOW BACK. SURGERY REVEALED TWO BROKEN VIPER 2PEEK RODS ON LEVELS L3-L5. SEE MFG MEDWATCH REPORT # 1526439-2011-00091 FOR THE OTHER ROD THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM 5.5 PEEK, PRELORDOSED ROD SPINAL FIXATION DEVICE NQP DEPUY SPINE, INC. NA 5060979

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention