BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSALOK ANCHOR, TI WITHOUT SUTURE

    MDR report key: 2080632 · Received April 25, 2011

    Report

    Report Number
    1221934-2011-00178
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 F/U REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT A PATIENT UNDERWENT A SUCCESSFUL ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF 2 VERSALOK ANCHOR FOR FIXATION ON (B)(6) 2011. AT SOME TIME POST-OPERATIVELY, THE PT PRESENTED WITH PAIN, AND IT WAS SOMEHOW DISCERNED THAT ONE OF THE TWO FIXATION DEVICES HAD MIGRATED OUT OF THE BONE-HOLE. THE PT UNDERWENT A SECOND SURGERY AT WHICH POINT THE SURGEON REMOVED THE LOOSE ANCHOR AND RE-FIXATED USING A MITEK FASTIN RC W/ORTHOCORD. THIS SECOND PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE WAS DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALOK ANCHOR, TI WITHOUT SUTURE SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK 210800 3433688

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention