BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDE BUL PAR 9X9X23

    MDR report key: 2973638 · Received February 22, 2013

    Report

    Report Number
    1526439-2013-12717
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    April 29, 2013
    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

    ADDITIONAL INFORMATION: THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF CAGE MIGRATION. HOWEVER, INVESTIGATIONS OF OTHER COMPLAINTS OF THIS NATURE DETERMINED THAT A HIGHER COMPLAINT RATE HAS BEEN EXPERIENCED IN (B)(4), SUGGESTING THAT THE ISSUE MAY BE TECHNIQUE RELATED IN THAT COUNTRY. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE CAGE MIGRATION OCCURRING IN JAPAN AND TO DOCUMENT THE CORRECTIVE ACTION ACTIVITIES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS GIVEN TO THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTERNATIONAL AFFILIATE REPORTED THAT L3-5 INSTRUMENTATION WAS PERFORMED ON PATIENT WITH SPONDYLOLISTHESIS. THE IMMEDIATE POST-OP X-RAY FOUND THE CONCORDE BULLET CAGE WAS IN PLACE. HOWEVER, TWO TO THREE WEEKS AFTER THIS SURGERY, THE CONCORDE BULLET CAGE WAS FOUND TO HAVE BACKED OUT/MIGRATED OUT OF POSITION. ADDITIONAL INFORMATION WAS RECEIVED FROM INTERNATIONAL AFFILIATE ON (B)(6) 2013 INDICATING THAT A SECOND CAGE HAD BEEN REMOVED DURING THE REVISION SURGERY AND THAT CAGE HAS ALSO BACKED OUT. THIS MEDWATCH REPORT IS BEING FILED FOR THE SECOND CAGE. SEE MFG MEDWATCH REPORT# 1526439-2013-12237 THAT WAS FILED FOR THE FIRST CONCORDE BULLET CAGE THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78379 CONCORDE BUL PAR 9X9X23 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE ANDC4Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention