BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM ANGLED ATTCHMNT

    MDR report key: 2213836 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02813
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVAL. HOWEVER, IT HAS NOT YET BEEN DELIVERED TO THE INVESTIGATION SITE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE DEVICE OVER-HEATED AT THE START OF THE PROCEDURE. A BACKUP SET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO MEDIUM ANGLED ATTCHMNT HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK