BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAMER IRRIGATOR ASPIRATOR

    MDR report key: 951193 · Received October 30, 2007

    Report

    Report Number
    MW5004485
    Event Type
    Injury
    Date Received
    October 30, 2007
    Manufacturer
    SYNTHES
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEN OF TWENTY PATIENTS HAD GRAFT - SITE COMPLICATIONS INCLUDING 4 NONUNIONS AND 6 DEEP INFECTIONS. OTA 2007 ABSTRACT. [SEE SCANNED PAGE]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAMER IRRIGATOR ASPIRATOR RIA (K042899) HTO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention