BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMERICAN ORTHOPAEDIC

    MDR report key: 3149727 · Received May 15, 2013

    Report

    Report Number
    1043537-2013-00001
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BSN MEDICAL, INC
    Product Code
    LGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAW WAS RETURNED, EVALUATION AN TESTED FOR ELECTRICAL AND FUNCTIONAL SAFETY. ALL TESTS PASSED, MEETING FINAL SPECIFICATIONS. FOLLOW UP COMMUNICATIONS WITH INITIAL REPORTER INDICATES THEY COMPLETED THEIR INTERNAL INVESTIGATION AND HAD DETERMINED (PER EMAIL/PHONE CALL FROM "(B)(6)", ENGINEERING ADMINISTRATOR) THAT PRODUCT HAD INDEED "BEEN OPERATING CORRECTLY, NO FUNCTIONING ISSUE RELATED TO PRODUCT AND THAT IT WAS A TECHNIQUE PROBLEM." INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214468 AMERICAN ORTHOPAEDIC SAW LGH BSN MEDICAL, INC 0295-200

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR