BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT JAVA

    MDR report key: 5652879 · Received May 13, 2016

    Report

    Report Number
    3003853072-2016-00039
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    March 24, 2016
    Report Date
    November 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 TWO OF FOUR FOR THE SAME EVENT, REFERENCE 3003853072-2016-00038 THROUGH 3003853072-2016-00041.

    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 TWO OF FOUR FOR THE SAME EVENT, REFERENCE 3003853072-2016-00038-1 THROUGH 3003853072-2016-00041-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED BLOCKERS WERE EXAMINED AND FOUND TO HAVE DAMAGED THREADS. THE COMPLAINTS ARE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT DETECT ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER DEVICE INSTALLATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED 09/16/2016 SHOWING THIS EVENT OCCURRED DURING TWO PROCEDURES DIFFERENT FROM THAT WHICH WAS ORIGINALLY REPORTED. THE TWO PROCEDURES WERE PERFORMED ON (B)(6) 2016. THE COMPLAINT DESCRIPTION REMAINS THE SAME. THE INVESTIGATION IS STILL ON-GOING SO NO CONCLUSIONS CANNOT BE DRAWN YET. A SUPPLEMENTAL WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    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
    308519 INSTINCT JAVA BLOCKER NKB ZIMMER SPINE N/A E86262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention