BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENGAL IMPLANT STD 5MM 7 DEG

    MDR report key: 3200048 · Received July 1, 2013

    Report

    Report Number
    1526439-2013-20249
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK031635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON JUNE 10TH, 2013 ¿ THAT PROCEDURE WAS A C3-6 ANTERIOR CERVICAL ACDF. TWO BENGAL IMPLANTS WERE PLACED INTO DISC SPACE. PHYSICIAN NOTICED THE IMPLANT AT C3-C4 WAS CRACKED. IT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. AT THAT POINT, THE PHYSICIAN NOTICED THE LEVEL ABOVE C4-5 WAS ALSO CRACKED. IT WAS REMOVED, THE WOUND WAS IRRIGATED (AS WAS THE PRIOR LEVEL) AND ANOTHER IMPLANT WAS PLACED. HOWEVER, IT WAS REPLACED WITH A 4MM GRAFT. VISUAL EXAMINATION NOTED THAT THE RETURNED 5MM BENGAL IMPLANTS HAD BEEN CRACKED. A REVIEW OF THE DHR ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW WITH GROUP MANAGER PD WAS CONDUCTED AND NO DEFINITIVE CONCLUSIONS COULD BE DRAWN. 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. A REVIEW OF THE TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. ALTHOUGH, NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE NOTED DAMAGE ON THE TWO (2) 5MM BENGAL IMPLANTS SUGGESTS THAT IT UNDERWENT AN OVERLOAD OF THE INSERTION TOOL ON IMPACTION RESULTING THE BENGAL IMPLANTS TO CRACK. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    PROCEDURE WAS C3-6 ANTERIOR CERVICAL ACDF. A 5MM BENGAL CAGE WAS FOUND TO BE CRACKED AFTER INSERTION. THE CAGE WAS REMOVED, THE SITE WAS IRRIGATED, AND ANOTHER 5MM BENGAL CAGE WAS PLACED. HOWEVER, A SECOND CAGE WAS ALSO FOUND TO HAVE BEEN CRACKED. THE DEVICES WERE REMOVED INTRA-OPERATIVELY AND REPLACED WITH 5MM AND 4MM BONE GRAFTS. THIIS MEDWATCH REPORT IS BEING FILED FOR THE FIRST BENGAL CAGE THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-20250 FOR THE SECOND BENGAL CAGE THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299857 BENGAL IMPLANT STD 5MM 7 DEG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE 5103249

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR