BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 1895431 · Received November 4, 2010

    Report

    Report Number
    9616696-2010-00328
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    March 22, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MFR FOR EVAL. LOT NUMBER INFO WAS NOT PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE THAT THE PERFORATOR 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. TBC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other