BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R/R TPS ELITE MEDIUM ATTACH.

    MDR report key: 1873421 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01172
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE DRILL ATTACHMENT HEATED UP. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R/R TPS ELITE MEDIUM ATTACH. DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC ERL STRYKER INSTRUMENTS KALAMAZOO 07351

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK