BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR RT. POST FOSSA POINTER

    MDR report key: 3089575 · Received May 2, 2013

    Report

    Report Number
    0001811755-2013-01002
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K002732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE INSPECTION THE BENT TIP OF THE POINTER WAS IDENTIFIED AS A PROBABLE CAUSE OF THE REPORT OF THE DEVICE NOT REGISTERING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROCEDURE WAS DELAYED BY 30 MINUTES BECAUSE THE POST FOSSA POINTER WAS BENT AND WAS OFF DURING REGISTRATION IN A CRANIOTOMY PROCEDURE. NO ADDITIONAL ANESTHESIA WAS REQUIRED; AN ALTERNATE POINTER WAS USED TO COMPLETED THE PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROCEDURE WAS DELAYED BY 30 MINUTES BECAUSE THE POST FOSSA POINTER WAS BENT AND WAS OFF DURING REGISTRATION IN A CRANIOTOMY PROCEDURE. NO ADDITIONAL ANESTHESIA WAS REQUIRED; AN ALTERNATE POINTER WAS USED TO COMPLETED THE PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192448 REPAIR RT. POST FOSSA POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1