BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATAK SUTURE ANCHOR WITH SUTURE

    MDR report key: 2222890 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01816
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON COULDN'T USE THE STATAK DUE TO THE TANGLES OF SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATAK SUTURE ANCHOR WITH SUTURE NONE MBI ZIMMER INC 252393

    Patients

    Seq Age Sex Outcome Treatment
    1