BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 2210689 · Received July 19, 2011

    Report

    Report Number
    9616696-2011-00114
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MFR FOR EVAL. LOT NUMBER INFO 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 PROCEDURE FOR A TEMPORAL CRANIOTOMY, THE PERFORATOR BIT TORE THE DURA. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention