BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILOK QUICKANCHOR PLUS W/#2/0 SUTURE

    MDR report key: 2030426 · Received March 18, 2011

    Report

    Report Number
    1221934-2011-00118
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 2, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD, AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT A PT UNDERWENT A SUCCESSFUL SCAPHOLUNATE LIGAMENT REPAIR (DATE UNDEFINED) WITH THE USE OF 3 MITEK MINILOK QUICKANCHOR PLUS FIXATION DEVICE. ON (B)(4) 2011, DURING A FOLLOW-UP EXAM, THE PT PRESENTED WITH LUCENCIES ON X-RAYS IN THE SCAPHOID AND LUNATE WHERE THE ANCHORS WERE PLACED IN ADDITION TO UNDERGOING SOME LYSIS NEAR THE SCAPHOID WAIST AND AN AUTO-FUSION OF HIS CAPITO-LUNATE JOINT; HOWEVER, NO PAIN OR SYNOVITIS. THE SURGEON IS OR HAS SCHEDULED AN MRI TO BETTER CHARACTERIZE WHAT IS GOING ON. THE SURGEON IS REACHING OUT FOR INFO AND/OR LITERATURE ABOUT THIS TYPE OF ISSUE. ALSO, SEE ASSOCIATED MDRS 1221934-2011-00051 AND 1221934-2011-00117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOK QUICKANCHOR PLUS W/#2/0 SUTURE SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212853 3391633

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention