BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS 1150001 UNIVERSAL TITANIUM CA

    MDR report key: 2863211 · Received December 10, 2012

    Report

    Report Number
    1045254-2012-00700
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    ETB
    PMA / PMN Number
    K002897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). MEDICAL INTERVENTION. THIS COMPLAINT IS BEING FILED AS A RESULT OF A LITERATURE REVIEW. NO PRODUCT WILL BE RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED AND THEREFORE, NO EVALUATION COULD BE PERFORMED. THE FOLLOWING CODES WERE NOT AVAILABLE IN MEDTRONIC'S GCH SYSTEM: 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 FROM THE ARTICLE PUBLISHED IN THE JOURNAL "ARCH OTOLARYNGOL HEAD NECK SURG" 2011 ENTITLED "TOTAL OSSICULOPLASTY IN CHILDREN: PREDICTIVE FACTORS AND LONG-TERM FOLLOW-UP," BY JEROME NEVOUX, MD; ANTOINE MOYA-PLANA, MD; PIERRE CHAUVIN, MD, PHD; FRANCOISE DENOYELLE, MD, PHD; EREA-NOEL GARABEDIAN, MD. AUTHOR AFFILIATIONS: UNIVERSITY PIERRE ET MARIE CURIE, UNIVERSITY PARIS 6 (DRS NEVOUX, MOYA-PLANA, DENOYELLE, AND GARABEDIAN), INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE U587, PASTEUR INSTITUTE (DRS DENOYELLE, AND GARABEDIAN), DEPARTMENT OF OTOLARYNGOLOGY-HEAD AND NECK SURGERY, ARMAND-TROUSSEAU CHILDREN'S HOSPITAL (DRS NEVOUX, MOYA-PLANA, DENOYELLE, AND GARABEDIAN), AND DEPARTMENT OF PUBLIC HEALTH, SAINT ANTOINE HOSPITAL (DR CHAUVIN), ASSISTANCE PUBLIQUE-HO PITAUX DE PARIS, AND INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE, UNITE´ MIXTE DE RECHERCHE EN SANTE´ 707 (DR CHAUVIN), PARIS, FRANCE. THE FOLLOWING EVENTS WERE REPORTED: OVER A PERIOD OF 15 YEARS, 116 EARS WERE OPERATED ON, INCLUDING 25 EARS THAT WERE SURGICALLY TREATED ON MORE THAN 2 OCCASIONS. SEVENTEEN EARS UNDERWENT A SECOND OPERATION FOR AN AUDITORY FAILING AND FOR REPLACEMENT OF THE PROSTHESIS. ONLY 4 CHILDREN WERE OPERATED ON BILATERALLY."...."THE AUDITORY RESULTS WERE UNSATISFACTORY IN 27 EARS AT 1 YEAR AFTER SURGERY. THREE WERE OPERATED ON LATER BECAUSE OF A VOLUMINOUS RESIDUAL CHOLESTEATOMA THAT WOULD NOT PERMIT OSSICULOPLASTY AT THE SAME TIME. PATIENT 6 PRESENTED WITH A NEW DISPLACEMENT OF THE PROSTHESIS 2 YEARS AFTER THE FIRST ONE, CONFIRMED BY CT FINDINGS, BUT HE DID NOT UNDERGO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTHESIS 1150001 UNIVERSAL TITANIUM CA PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT ETB MEDTRONIC, INC. 1150001 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention