BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE BULLET LOR 9X9X27, 5 DG

    MDR report key: 3856509 · Received June 9, 2014

    Report

    Report Number
    1526439-2014-11591
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    PMA / PMN Number
    PK052746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL VERIFICATION OF THE CAGE CONFIRMED THAT THE CAGE HAD FRACTURED INTO 2 SEGMENTS. A DHR SEARCH WAS CONDUCTED. THE CAGE WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A COMPLAINT TREND ANALYSIS WAS CONDUCTED ON THE PRODUCT CODE. NO SYSTEMIC TREND WAS IDENTIFIED REQUIRING FURTHER ACTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. AS NOTE IN THE ACCOMPANYING IFU, EXCESSIVE TORQUE AND/OR IMPACTION FORCES APPLIED DIRECTLY TO A SMALL SURFACE OF THE IMPLANT CAN CAUSE FRACTURE OF THE IMPLANT. AS NO ISSUE HAS BEEN IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THE DEVICE AND NO SYSTEMIC COMPLAINT TREND HAS BEEN IDENTIFIED THE COMPLAINT FILE IS BEING CLOSED REQUIRING NO FURTHER ACTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE SURGERY INVOLVING L4-5 INSTRUMENTATION WITH VIPER2/CONCORDE SYSTEMS FOR THE PATIENT WITH LUMBAR CANAL STENOSIS WAS CONDUCTED ON (B)(6) 2014. IT WAS NOTED THAT THE CAGE WAS BROKEN DURING THE INSERTION. ALL BROKEN PIECES WERE COLLECTED AND REMOVED FROM THE PATIENT¿S BODY DURING THE PROCEDURE. AFFILIATE REPORTS ¿LIGHT INJURY¿ TO THE PATIENT¿S DURA WAS NOTED WHEN THE SURGEON WAS REMOVING THE BROKEN CAGE. REPORTS IT WAS POSSIBLE THAT THE INSERTER USED AT THE SURGERY WAS OWNED BY THE HOSPITAL AND MAY NOT HAVE BEEN ONE FROM THE CONCORDE SYSTEM. THE PROCEDURE WAS EXTENDED BY FORTY MINUTES AS A RESULT OF THE DIFFICULTY. THE PATIENT IS REPORTED TO HAVE RECEIVED UNSPECIFIED TREATMENT FOR THE DAMAGE TO DURA. THERE WERE NO AFTER EFFECTS AND NO PROLONGED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333628 CONCORDE BULLET LOR 9X9X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE APLBBD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN INSERTER INSTRUMENT