BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 328766 · Received April 25, 2001

    Report

    Report Number
    1221934-2001-00024
    Event Type
    Injury
    Date Received
    April 25, 2001
    Date of Event
    February 26, 2001
    Report Date
    April 25, 2001
    Manufacturer
    MITEK
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGERY IN 2001 FOR REPAIR OF ROTATOR CUFF. 7 WEEKS LATER, THE PT WAS TAKEN BACK TO SURGERY TO REMOVE A DISPLACED ANCHOR THAT WAS PLACED DURING THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19107 ARCS ANCHORS RC QUICK PLUS HWC MITEK 212031 0010055

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention