BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INTERVENTIONAL SPINE DEKOMPRESSOR

    MDR report key: 2460654 · Received February 17, 2012

    Report

    Report Number
    2460654
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    February 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DECOMPRESSION PROCEDURE, THE WIRE WAS NOTED TO BE BROKEN FROM THE PERCUTANEOUS PROBE IN THE PATIENTS BACK AT L5-S1. NEUROSURGEON SUCCESSFULLY REMOVED THE WIRE THAT DID NOT REQUIRE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INTERVENTIONAL SPINE DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE 6" 15G HRX STRYKER INSTRUMENTS 10289012

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention