BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 297680 · Received September 27, 2000

    Report

    Report Number
    1221934-2000-00041
    Event Type
    Injury
    Date Received
    September 27, 2000
    Date of Event
    December 30, 1999
    Report Date
    September 27, 2000
    Manufacturer
    MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A LETTER FROM AN ATTORNEY ALLEGES A MITEK ANCHOR BROKE AT THE BARB CAUSING THE PT TO EXPERIENCE PAIN AND REQUIRING A SECOND SURGERY TO REMOVE THE BROKEN PIECE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN