BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS 1112065 H/A PARTIAL 90DEG REC

    MDR report key: 2863078 · Received December 10, 2012

    Report

    Report Number
    1045254-2012-00699
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 6, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETA
    PMA / PMN Number
    K810707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THIS IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNING. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: ACTUAL DEVICE NOT EVALUATED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A LITERATURE REVIEW WAS PERFORMED ON AN ARTICLE PUBLISHED IN THE JOURNAL "OTOLOGY <(>&<)> NEUROTOLOGY" IN 2010 ENTITLED, "TITANIUM VERSUS NONTITANIUM OSSICULAR PROSTHESES - A RANDOMIZED CONTROLLED STUDY OF THE MEDIUM-TERM OUTCOME," BY MATTHEW YUNG AND PHILIP SMITH. THE ARTICLE DISCUSSED A STUDY COMPARING THE MEDIUM-TERM OUTCOME OF OSSICULOPLASTY USING TITANIUM (TI) AND NON-TI PROSTHESES. THE STUDY WAS CONDUCTED BETWEEN 2002 AND 2007 ON PATIENTS WHO REQUIRED OSSICULAR RECONSTRUCTIONS AND HAD CASES OF CHRONIC OTITIS MEDIA. THE PATIENT DEMOGRAPHICS INCLUDED BOTH MALES AND FEMALES RANGING FROM 10 TO 78 YEARS IN AGE, 8 OF WHICH WERE 16 YEARS OF AGE OR YOUNGER. OF 94 OSSICULOPLASTIES RECRUITED, 45 WERE HA PROSTHESIS AND FROM THIS 19 WERE HA TORP AND 26 WERE HA PORP. MEDTRONIC PRODUCTS WERE USED IN ONLY THE NON-TI CASES WHERE THE FOLLOWING ISSUES REPORTED: 1.) PROSTHESIS EXTRUSION OR EXPOSURE OF HEAD PLATE VERSUS NON-EXTRUSION (2 CASES) 2.) CARTILAGE PLATES PLACED OVER THE HEAD PLATE OF THE HA PROSTHESES IN CASES OF ATELECTASIS. (CASES NOT SPECIFIED) POINTS REPORTED IN THE ARTICLE: 1.) NO SIGNIFICANT DIFFERENCE BETWEEN TI (NON-MEDTRONIC PRODUCT) AND NON-TI (MEDTRONIC PRODUCT)FOR BOTH PORPS AND TORPS. 2.) NO SIGNIFICANT DIFFERENCE IN THE EXTRUSION RATE BETWEEN BOTH PROSTHESES. 3.) RESULT OF STUDY IS CONSISTENT WITH THOSE OF A PREVIOUS LONG-TERM STUDY ON OSSICULOPLASTY OUTCOMES SHOWING INFLUENCE BY MIDDLE EAR PATHOLOGIES RATHER THAN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS 1112065 H/A PARTIAL 90DEG REC PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT ETA XOMED MFG JACKSONVILLE 1112065 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)