BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD IMPLT 5DEG, LRDTC,28X7

    MDR report key: 3142740 · Received June 3, 2013

    Report

    Report Number
    1526439-2013-18040
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK031635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. REMOVED FRAGMENT DISCARDED.

    Additional Manufacturer Narrative · 1

    THE CAGE IS NOT AVAILABLE FOR EVALUATION AND THE LOT CODE IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. EXAMINATION OF A PROVIDED PHOTO CONFIRMED DEVICE BREAKAGE. HOWEVER, THE CAUSE OF THE BREAKAGE CANNOT BE DETERMINED. AS NOTED IN THE ACCOMPANYING IFU, EXCESSIVE TORQUE APPLIED WITH LONG HANDLED INSERTION TOOLS CAN CAUSE SPLITTING OR FRACTURE OF THE CARBON FIBER IMPLANTS, ALSO IMPACTION FORCES APPLIED DIRECTLY TO A SMALL SURFACE CAN CAUSE FRACTURE TO THE IMPLANT. IT IS RECOMMENDED THAT THE USER CLEAR AND PROPERLY DISTRACT THE DISC SPACE AND TRIAL PRIOR TO DISC PLACEMENT. THE INSERTER IS NOT DESIGNED TO TORQUE OR DRIVE THE IMPLANT OR TO BE VIGOROUSLY IMPACTED WITH A MALLET. THE SYSTEM COMES WITH A STRAIGHT AND CURVED IMPACTOR TO ADVANCE THE IMPLANT INTO FINAL POSITION WITH MALLET. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND PRODUCT EVALUATED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE LEOPARD CAGE WAS IMPACTED IN PLACE AND AS THE INSERTION INSTRUMENT WAS REMOVED, IT WAS FOUND THAT APPROXIMATELY HALF OF THE LEOPARD CAGE BROKE OFF FROM THE IMPLANT. THE REMOVED SECTION WAS DISCARDED BY THE CUSTOMER AND THE REMAINING CAGE SECTION WAS LEFT IN-SITU SURROUNDED BY BONE GRAFT THAT WAS TIGHTLY PACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244458 LEOPARD IMPLT 5DEG, LRDTC,28X7 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1