BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 530801 · Received June 21, 2004

    Report

    Report Number
    1221934-2004-00081
    Event Type
    Injury
    Date Received
    June 21, 2004
    Date of Event
    January 1, 2003
    Report Date
    June 18, 2004
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PERSON FILLED OUT THE FEEDBACK FORM ON THE DEPUY MITEK WEB PAGE AND STATED THAT THERE WAS A PT INFECTION IN 2003.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN