BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUCTILE ROD LENGTH 500

    MDR report key: 7650156 · Received June 29, 2018

    Report

    Report Number
    3003853072-2018-00054
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    April 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PNA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). ADDITIONAL INFORMATION IN ETHNICITY, UDI NUMBER, METHOD, RESULTS, AND CONCLUSIONS. THE ROD WAS NOT RETURNED, HOWEVER A PHOTO, VIDEO, AND X-RAYS WERE PROVIDED AND USED FOR EVALUATION, BUT THE RESULTS ARE INCONCLUSIVE WITH THE AVAILABLE INFORMATION. THE USE OF A JAVA ROD WITH AN INSTINCT BLOCKER AND SCREW IS NOT INDICATED WITHIN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ROD WAS FOUND TO HAVE MIGRATED POST-OPERATIVELY WHICH NECESSITATED A REVISION SURGERY. DURING THE REVISION, THE ROD, PEDICLE SCREW, AND BLOCKER WERE REMOVED. THE SURGEON WAS NOT ABLE TO INSTALL A NEW CONSTRUCT BECAUSE THE HOLE IN THE PEDICLE FOR THE SCREW WAS TOO BIG. SO CEMENT WAS USED FOR TEMPORARY FIXATION. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT CLEARED FOR USAGE WITHIN THE US. HOWEVER IT IS SIMILAR TO THE RODS CLEARED UNDER K111301, PRODUCT CODE NKB. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3003853072-2018-00052 THRU 3003853072-2018-00054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROD WAS FOUND TO HAVE MIGRATED POST-OPERATIVELY WHICH NECESSITATED A REVISION SURGERY. DURING THE REVISION, THE ROD, PEDICLE SCREW, AND BLOCKER WERE REMOVED. THE SURGEON WAS NOT ABLE TO INSTALL A NEW CONSTRUCT BECAUSE THE HOLE IN THE PEDICLE FOR THE SCREW WAS TOO BIG. SO CEMENT WAS USED FOR TEMPORARY FIXATION. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495091 DUCTILE ROD LENGTH 500 JAVA TOP LOADING KWQ ZIMMER SPINE NA E105159

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R