BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 IN 1 DRILL

    MDR report key: 1689236 · Received May 5, 2010

    Report

    Report Number
    2032499-2010-00001
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    April 6, 2010
    Report Date
    May 5, 2010
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    PMA / PMN Number
    K062391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. A REVIEW OF THE MFG RECORDS REVEALED THAT THESE INSTRUMENTS WERE MANUFACTURED ACCORDING TO REQUIREMENTS; THERE WAS NO EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. ADDITIONALLY THE COMPLAINT LOG WAS REVIEWED; THERE HAVE BEEN NO OTHER REPORTED INCIDENTS AGAINST THESE PRODUCT LOT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L3-4, L4-5 LAMINECTOMY PROCEDURE THE DISTAL TIP OF A DRILL BIT BROKE OFF. THE FRAGMENT REMAINS WITHIN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 IN 1 DRILL DRILL BIT MRW INTERVENTIONAL SPINE, INC. 6070 042709G/042709J

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR