BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 4730573 · Received April 24, 2015

    Report

    Report Number
    3007738819-2015-00002
    Event Type
    Injury
    Date Received
    April 24, 2015
    Date of Event
    March 26, 2015
    Report Date
    March 30, 2015
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    PMA / PMN Number
    K080065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO IRREGULARITIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, AFTER A LEFT OSTEOTOMY PROCEDURE THE SCREWS ARE BACKING OUT OF THE PLATE AND THIS PRODUCT (OSFERION WEDGE) SPIT OUT OF THE BONE. FOLLOW UP INVESTIGATION: PT WAS COMPLIANT IN ALL POST OP PROTOCOL. THERE IS NO PLAN FOR A REVISION TO DATE. X-RAYS INDICATE THERE IS A GAP AROUND THE WEDGE IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274319 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY M14309B402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other