BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS BLOCKER

    MDR report key: 2894503 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00598
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    OPERATING NURSE FLEUR WESSELINK REPORTED ON BEHALF OF DR FELLER: PT NEEDED REVISION SURGERY. ONE BLOCKER HAD ALREADY COMPLETELY FALLEN OUT OF THE SCREW AND THE OTHER BLOCKERS WERE LOOSE. DR. FELLER IS QUESTIONING HOW THIS COULD HAPPEN AND IF THE FINAL TIGHTENER / TORQUE WRENCH IS STILL FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OASYS TORQUE WRENCH| OASYS BLOCKERS