BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK ABSORBABLE ANCHOR IMPLANT

    MDR report key: 4725557 · Received April 24, 2015

    Report

    Report Number
    1221934-2015-00718
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    March 26, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS 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.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FORWARDED TO US BY OUR MEDICAL SAFETY TEAM WHO REVIEWED A JOURNAL ARTICLE WHERE A DEPUY MITEK SPIRALOK ANCHOR WAS USED. THE PATIENT HAD A SHOULDER PROCEDURE SOMETIME BETWEEN 2007 AND 2009. SIX TO TWELVE MONTHS POSTOPERATIVELY, THE PATIENT REQUIRED SURGERY TO REMOVE THE ANCHOR. TITLE: ARTHROSCOPIC SUTURE-BRIDGE REPAIR FOR SMALL TO MEDIUM SIZE SUPRASPINATUS TEAR: HEALING RATE AND RETEAR PATTERN AUTHORS: LIONEL NEYTON, M.D., ARNAUD GODENÈCHE, M.D., LAURENT NOVÉ-JOSSERAND, M.D., YANNICK CARRILLON, M.D., JULIEN CLÉCHET, M.D., AND MARIE BÉATRICE HARDY, M.D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272711 MITEK ABSORBABLE ANCHOR IMPLANT ANCHOR IMPLANTS LXH DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other