BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XOM UNKNOWN ENDO

    MDR report key: 4182376 · Received October 17, 2014

    Report

    Report Number
    1045254-2014-00258
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED, THE DEVICE REMAINS IMPLANTED IN THE PATIENT. METHODS: NO TESTING METHODS PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS INFECTIONS FROM THE SUTURE AND THE SCREW OF THE REPOSE HYOID SYSTEM. THE REPOSE HYOID SUSPENSION WAS IMPLANTED IN THE PATIENT AT (B)(6) IN 1999. THE PATIENT STARTED SEEING A DOCTOR IN (B)(6), IN 2004. IT IS NOT KNOWN WHEN THE PATIENT STARTED EXPERIENCING THE INFECTIONS. DOCTOR THINKS HE REMOVED THE INFECTED SUTURE BUT CANNOT CONFIRM. THE PATIENT¿S BODY IS TREATING THE SCREW THAT IS IN THE POSTERIOR MANDIBLE ALSO AS A FOREIGN BODY AND IT IS GETTING CHRONICALLY INFECTED. THE DOCTOR PLANS ON REMOVING THE SCREW FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661748 XOM UNKNOWN ENDO EQJ MEDTRONIC XOMED INC. XOM UNKNOWN ENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention