BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 125070 · Received September 24, 1997

    Report

    Report Number
    125070
    Date Received
    September 24, 1997
    Date of Event
    July 17, 1997
    Manufacturer
    EBI
    Product Code
    HTY
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT OPEN WEDGE OSTEOTOMY ON 07/01/97 WITH PLACEMENT OF AN EBI EXTERNAL FIXATOR".1.5 WEEKS POSTOP FIXATOR JAMMED. MANUFACTURER REP. WAS NOTIFIED AND SAW THE PATIENT. NO EXPLANATION FOR FAILURE. PATIENT WAS RETURNED TO THE OPERATING ROOM FOR FIXATOR REMOVAL AND REPLACEMENT ON 07/17/97. REPRESENTATIVE FELT THE PROBLEM WAS "MANUFACTURER ERROR". PROBLEM NOT DETERMINED, MECHANISM "FROZE". REPRESENTATIVE TOOK THE PART AND RETURNED IT TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant EXTERNAL FIXATOR HTY EBI EBI *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN