BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSLOK ANCHOR

    MDR report key: 907567 · Received September 5, 2007

    Report

    Report Number
    1221934-2007-00236
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    August 1, 2024
    Report Date
    August 24, 2007
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE JUST BEEN MADE AWARE OF THIS EVENT AND WE ARE GATHERING INFORMATION TOWARDS CLARITY. A FOLLOW-UP REPORT WILL DETAIL OUR FINDINGS.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING A ROUTINE POST-OP FOLLOW-UP EXAMINATION FOR A SHOULDER REPAIR, AN X-RAY WAS TAKEN. IT WAS NOTED THAT 1 OF THE 2 VERSALOK ANCHORS USED 4 WEEKS PREVIOUSLY FOR THE ORIGINAL REPAIR HAD STARTED TO MIGRATE OUT OF THE BONE HOLE INTO THE JOINT SPACE. A REVISION SURGERY WAS PERFORMED IN 2007, THE FLOATING DEVICE WAS REMOVED FROM THE PT'S BODY. FOR REMEDY, THE SURGEON PERFORMED A MINI OPEN AND USED A PANALOK RC FOR FIXATION. THIS SECOND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. [THIS MDR IS ASSOCIATED WITH 1221934-2007-00230, 1221934-2007-002331 1221934-2007-00233, 1221934-2007-00234 & 1221934-2007-00235. THIS IS VIA THE FACT THAT ALL OF THESE EVENTS EMANATE FROM THE SAME FACILITY AND THE SAME SURGEON.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSLOK ANCHOR SOFT TISSUE FIXATION DEVICE MAI DEPUY MITEK 210808 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention