BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS ADJUSTABLE DRILL GUIDE

    MDR report key: 2894511 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00606
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    DZJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT, "DURING TRAY INSPECTION PRIOR TO A CASE DISCOVERED THE ADJUSTABLE DRILL GUIDE BALL WAS BROKEN TO SET THE DEPTH OF THE DRILL GUIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS ADJUSTABLE DRILL GUIDE INSTRUMENT DZJ STRYKER SPINE BORDEAUX NA 11D121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK