BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADD+

    MDR report key: 2833042 · Received November 5, 2012

    Report

    Report Number
    9612420-2012-00012
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    MQP
    PMA / PMN Number
    K090841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE LOOK AFTER THE PRODUCTION ORDER AND THE MATERIAL SPECIFICATIONS AND THERE WERE NO MEANDERINGS.

    Description of Event or Problem · 1

    THE PT RECEIVED AN "ADD+ APPR" ONE YEAR AGO. DURING THE X-RAY CONTROL WITH FUNCTION TESTS, IT WAS DETECTED THAT THE IMPLANT DID NOT MAINTAIN ITS HEIGHT. "IT GROWS." THREE MONTHS AGO THE PT HAD A REVISION OPERATION. THE PT HAS NO DISCOMFORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD+ ADD+ MQP ULRICH GMBH & CO. KG ADD+ WSA14714698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization STERILIZATION PROCESS| NONSTERAL IMPLANT, HOSPITAL PERFORMS REPEATED