BEUDAMED
    FDA Adverse Event Summary report: N

    HTR-PMI RATNER BI FRT

    MDR report key: 1875227 · Received October 19, 2010

    Report

    Report Number
    1032347-2010-00181
    Date Received
    October 19, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    K924935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF THE DEVICE NOT FUNCTIONING PROPERLY. THE ISSUE WAS THE 1 HOUR DELAY IN THE CASE, AS THE HOSPTIAL DID NOT HAVE THE NEEDED ITEMS READILY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE HOSPITAL DID NOT HAVE THE IMPLANTS NEEDED FOR A SURGERY, WHILE GETTING THEM DELIVERED AND STERILIZED, THERE WAS ABOUT A HOUR DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR-PMI RATNER BI FRT HARD TISSUE REPLACEMENT/ PATIENT MATCHED IMPLANT GXN BIOMET MICROFIXATION 281290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization