BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3289550 · Received August 9, 2013

    Report

    Report Number
    3007738819-2013-00001
    Event Type
    Other
    Date Received
    August 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 16, 2013
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP. FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DEVICE USED AFTER EXPIRATION DATE. A DEVICE PAST EXPIRY WAS IMPLANTED DURING HTO (HIGH TIBIAL OSTEOTOMY) PRESSURE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381203 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION BH07Z007

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR