BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1333081 · Received February 23, 2009

    Report

    Report Number
    1333081
    Event Type
    Malfunction
    Date Received
    February 23, 2009
    Date of Event
    December 17, 2008
    Report Date
    February 13, 2009
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    IN THE COURSE OF REMOVING MULTIPLE SMALL AND MEDIUM SIZED FRAGMENTS OF DEGENERATIVE DISC MATERIAL WITH THE PITUITARY RONGEURS, THE TIP OF THE INSTRUMENT BROKE OFF IN THE INTERSPACE. IT WAS SUCCESSFULLY RETRIEVED WITH COMBINATION USE OF A BLUNT HOOK AND A LARGE STRAIGHT PITUITARY RONGEUR. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION AND THE PATIENT TOLERATED THE PROCEDURE WELL. THIS DID NOT CAUSE AN EXTENSION OF THE PATIENT'S LENGTH OF STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PITUITARY RONGEURS HTX BOSS INSTRUMENTS, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR