BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEOPARD IMPLT 5DEG, LRDTC,28X1

    MDR report key: 3140318 · Received May 31, 2013

    Report

    Report Number
    1526439-2013-17947
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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. DEVICE DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CAGE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. THE CAUSE OF CAGE BREAKAGE CANNOT BE POSITIVELY DETERMINED. HOWEVER, 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. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. 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 CAGE BROKE WHEN IMPACTED BETWEEN VERTEBRAL BODIES. THE SURGEON REMOVED THE SMALL FRAGMENTS AND INSERTED ANOTHER LEOPARD CAGE. THE DIFFICULTY RESULTED IN A TWENTY FIVE MINUTE DELAY. HOWEVER, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    THE DIFFICULTY RESULTED IN A DELAY OF THIRTY FIVE MINUTES. NOT TWENTY FIVE MINUTES AS ORIGINALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241739 LEOPARD IMPLT 5DEG, LRDTC,28X1 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1