BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 530791 · Received June 22, 2004

    Report

    Report Number
    1221934-2004-00083
    Event Type
    Injury
    Date Received
    June 22, 2004
    Report Date
    June 17, 2004
    Manufacturer
    DEPUY MITEK
    Product Code
    NOV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A STATEMENT WAS MADE TO A DEPUY MITEK EMPLOYEE THAT THERE WAS A PT INFECTION INVOLVING A DEPUY MITEK PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCS ANCHORS BONE ANCHOR NOV DEPUY MITEK * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN