BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEK 3" 19 GAUGE STRAIGHT

    MDR report key: 2190258 · Received July 19, 2011

    Report

    Report Number
    2648666-2011-00172
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.

    Description of Event or Problem · 1

    AT THE END OF A CERVICAL DISCECTOMY PROCEDURE, THE PROBE BROKE. IT WAS REMOVED WITH FORCEPS. IT WAS FURTHER REPORTED THAT THIS DID NOT CAUSE ANY DELAY AND THAT THE PHYSICIAN CONSIDERED THE PROCEDURE COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEK 3" 19 GAUGE STRAIGHT HRX STRYKER INSTRUMENTS PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR