BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRALOK ANCHOR

    MDR report key: 1122757 · Received August 18, 2008

    Report

    Report Number
    1221934-2008-00408
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 EVALUATED, THE RESULT OF THE INVESTIGATION WILL BE THE SUBJECT MATTER OF THE F/U REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT A PT UNDERWENT AN ARTHROSCOPIC SHOULDER REPAIR IN 2008, WITH THE USE OF A SPIRALOK ANCHOR FOR FIXATION. AT SOME POINT IN TIME SUBSEQUENT, THE PT PRESENTED WITH SOME SORT OF SYMPTOM OR REACTION, AND IT WAS SOMEHOW DISCERNED THAT THE HEAD OF THE SPIRALOK HAD BROKEN AWAY FROM THE BODY OF THE ANCHOR. A RE-SURGERY WAS PERFORMED THREE MONTHS LATER, THE FRAGMENT WAS REMOVED, THE BODY OF THE ANCHOR REMAINS BURIED IN THE BONE. THE SURGEON RE-FIXATED USING A SAME TYPE DEVICE. THIS RE-SURGERY WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. NOTHING BEING RETURNED TO MITEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRALOK ANCHOR SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 222986 3109764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention