BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3112356 · Received May 14, 2013

    Report

    Report Number
    6000034-2013-00887
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABUTMENT TIGHTENED TO THE FIXTURE IN THE OPERATING ROOM ON (B)(6) 2013, IS NOT AVAILABLE FOR ANALYSIS. PER THE SURGEON, THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE ABUTMENT ON (B)(6) 2013. DURING THE ABUTMENT REPLACEMENT, IT WAS DETERMINED THAT A NON-COMPATIBLE ABUTMENT MODEL HAD BEEN PLACED ON THE FIXTURE DURING THE PROCEDURE ON (B)(6) 2013. THE CORRECT ABUTMENT MODEL WAS IDENTIFIED AND PLACED. THE ABUTMENT REPLACEMENT OCCURRED IN THE OPERATING ROOM AND THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. A DEVICE ANALYSIS FOR THE ABUTMENT INVOLVED IN THE PROCEDURE ON (B)(6) 2013, WILL NOT BE COMPLETED SINCE THE ABUTMENT REPLACEMENT RESULTED FROM THE USE OF NON-COMPATIBLE PRODUCTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO TIGHTEN THE ABUTMENT ON THE INTERNAL FIXTURE. THE PROCEDURE TOOK PLACE IN THE OPERATING ROOM AND THE PATIENT WAS SEDATED FOR THE PROCEDURE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212276 FLANGE FIXTURE AND ABUTMENT PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92346

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention