BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PANALOK ANCHOR

    MDR report key: 6635440 · Received June 12, 2017

    Report

    Report Number
    1221934-2017-10286
    Event Type
    Injury
    Date Received
    June 12, 2017
    Report Date
    May 15, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHOR BUT THE AUTHOR COULD NOT PROVIDE ANYMORE INFORMATION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI - UNAVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CORACOID BONE BLOCK VERSUS ARTHROSCOPIC BANKART REPAIR: A COMPARATIVE PAIRED STUDY WITH 5 YEAR FOLLOW-UP. AUTHORS: BESSIERE C., TROJANI C., PELEGRI C., CARLES M., AND BOILEAU P. ORTHOPAEDICS AND TRAUMATOLOGY: SURGERY & RESEACH (2013) 99, 123-130 HTTP: //DX.DOI.ORG/10.1016/J.OTSR.2012.12.010. (B)(6). N=2 REVISION SURGERY FOR RECURRENT INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414107 UNK PANALOK ANCHOR MITEK ANCHOR IMPLANTS MAI DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other