BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6" 17G CURVED DEK KIT

    MDR report key: 2442101 · Received February 1, 2012

    Report

    Report Number
    2648666-2012-00038
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    December 27, 2011
    Report Date
    January 6, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEFT L4-5 AND L5-S1 PERCUTANEOUS DISCECTOMY, AS THE PHYSICIAN WENT TO REMOVE THE PROBE FROM THE INTRODUCER CANNULA THE PROBE NEEDLE HAD BROKEN OFF LEAVING ABOUT 1/2 INCH OF THE PROBE HANDLE AND ABOUT 5 INCHES OF NEEDLE REMAINING IN PATIENT. THE NEEDLE WAS VISUALIZED UNDER FLUORO AND THE PATIENT HAD AN INCISION MADE TO OPEN TH AREA. THE NEEDLE WAS REMOVED ENTIRELY. FLUOROSCOPY CONFIRMED ENTIRE NEEDLE REMOVAL. THE PATIENT WAS THEN CLOSED AND THE PROCEDURE WAS NOT CONTINUED. PATIENT TRANSFERRED TO RECOVERY AND DISCHARGED TO HOME OUTPATIENT. NO OTHER ADVERSE CONSEQUENCES WERE REPORTED RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6" 17G CURVED DEK KIT HRX STRYKER INSTRUMENTS PUERTO RICO 11118012

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R