BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT JAVA

    MDR report key: 5652892 · Received May 13, 2016

    Report

    Report Number
    3003853072-2016-00042
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    March 31, 2016
    Report Date
    April 14, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111301
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT ONE OF FIVE FOR THE SAME EVENT, REFERENCE 3003853072-2016-00043 THROUGH 3003853072-2016-00046.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT ONE OF FIVE FOR THE SAME EVENT, REFERENCE 3003853072-2016-00043-1 THROUGH 3003853072-2016-00046-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY EXAMINED. THE THREADS WERE DAMAGED IN A MANNER CONSISTENT WITH CROSS-THREADING. THERE WERE NO MANUFACTURING ISSUES DETECTED THAT WOLD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS FOR PROPER ASSEMBLY.

    Description of Event or Problem · 1

    IT IS REPORTED THE SCREWDRIVER BROKE DURING THE FINAL TIGHTENING STEP AND SEVERAL BLOCKERS BROKE WHEN THE SURGEON TRIED TO TIGHTEN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308904 INSTINCT JAVA BLOCKER NKB ZIMMER SPINE N/A E75563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention