BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH

    MDR report key: 2922355 · Received January 14, 2013

    Report

    Report Number
    MW5028640
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANSPACH COMPANIES
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING AN ANSPACH DRILL BIT FOR HIS PATIENT WHO WAS UNDERGOING A SPINAL CORD UNTETHERING ON (B)(6) 2013 AND THE BURR (BIT OR CUTTING TIP) BROKE OFF AS HE WAS DRILLING. THE SURGEON WAS VERY CONCERNED AS THIS COULD HAVE BEEN AN ADVERSE EVENT FOR THE CHILD. THE PACKAGING AND BIT WAS RETURNED TO THE REPRESENTATIVE. BIT INFORMATION IS P-CRN 1.4 MM X 12.8 MM FLUTED ROUTER LOT #F533073672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20468 ANSPACH BURR BIT HBB ANSPACH COMPANIES F533073672

    Patients

    Seq Age Sex Outcome Treatment
    1