BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO OSTEON 500

    MDR report key: 954900 · Received November 27, 2007

    Report

    Report Number
    2242816-2007-00057
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 1, 2007
    Manufacturer
    EBI
    Product Code
    MQV
    PMA / PMN Number
    K000515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE WAS NOT RETURNED FOR EVAL, THE DHR AND SHIPPING RECORDS FOR THE LOT INVOLVED WERE REVIEWED. DHR SHOWS THAT THE PART WAS MADE TO REQUIRED SPECIFICATIONS. THE EXPIRATION DATE WAS CLEARLY IDENTIFIED ON THE LABELING ACCORDING TO ESTABLISHED SPECIFICATIONS. SHIPPING RECORDS SHOW THAT THE DEVICE WAS SHIPPED PRIOR TO THE EXPIRATION DATE.

    Description of Event or Problem · 1

    EXPIRED PRO OSTEON (EXPIRATION DATE OF APRIL 2007) WAS IMPLANTED. PT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON 500 MQV EBI 204803

    Patients

    Seq Age Sex Outcome Treatment
    1 YR