BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS PRECISION NEURO, 2.5 MM

    MDR report key: 3133695 · Received May 29, 2013

    Report

    Report Number
    0001811755-2013-01220
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K303032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BUR WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION) PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE SURGEON HAD TO REMOVE AN ALREADY INSTALLED SCREW TO RETRIEVE THE BROKEN PIECE OF BUR, THEN PUT THE SCREW BACK IN SUCCESSFULLY. IT WAS FURTHER REPORTED THERE WERE NO PIECES OF BUR LEFT BEHIND IN THE PATIENT; THE PROCEDURE WAS DELAYED BY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236316 MIS PRECISION NEURO, 2.5 MM DRILLS, BURRS, TREPHINES & ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4), LOT 12265