BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 1913835 · Received November 29, 2010

    Report

    Report Number
    9616696-2010-00352
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL SURGICAL PROCEDURE, THE PERFORATOR BIT TORE THE DURA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORATOR BIT LARGE 14/11MM DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other