BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5923799 · Received September 1, 2016

    Report

    Report Number
    6000034-2016-01658
    Event Type
    Injury
    Date Received
    September 1, 2016
    Report Date
    October 11, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 IN ORDER TO PLACE AN INTERNAL MAGNET. THIS REPORT IS FILED ON NOVEMBER 14, 2016. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011.

    Additional Manufacturer Narrative · 0

    INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT. REGISTRATION NUMBER 3009092818 EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON SEPTEMBER 02, 2016 BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENTS DEVICE HAS BEEN EXPLANTED (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT SEPTEMBER 02, 2016.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT'S ABUTMENT WAS REMOVED DUE TO INFECTIONS AT THE IMPLANT SITE; HOWEVER, THE IMPLANTED DEVICE REMAINS INSITU. SUBSEQUENT TO THE ABUTMENT REMOVAL, THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DATE AND DURATION NOT REPORTED). PRIOR TO THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE IMPLANT SITE. CORRECTION: THE CORRECT MODEL CODE IS BIA400, NOT BIA210 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT CATALOG # IS 93332, NOT 92135 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT 510(K)# IS K121317, NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED SEPTEMBER 19, 2016. IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574432 FLANGE FIXTURE AND ABUTMENT MAH MAH COCHLEAR LTD BIA400 175199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention