BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 5511864 · Received March 18, 2016

    Report

    Report Number
    6000034-2016-00585
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 9, 2016
    Report Date
    September 22, 2025
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D1: CORRECT BRAND NAME IS BIA400 IMPLANT 4 MM W ABUTMENT 8 MM, NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED IN THE INITIAL REPORT [6000034-2016-00585]. CORRECTION D2: CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM, PRODUCT CODE: MAH, NOT LXB AS PREVIOUSLY REPORTED IN THE INITIAL REPORT [6000034-2016-00585]. CORRECTION G5: CORRECT PMA/510(K) IS K121317, NOT K955713 AS PREVIOUSLY REPORTED IN THE INITIAL REPORT [6000034-2016-00585]. PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC IRRITATION, RECURRENT WEEPING FROM THE SURROUNDING SKIN OF THE ABUTMENT, AND MILD PAIN. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS ON (B)(6) 2016 (DURATION NOT REPORTED); HOWEVER, THIS TREATMENT DID NOT RESOLVE THE SYMPTOMS. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016, UNDER GENERAL ANESTHESIA TO FULLY REMOVE THE GRANULATED TISSUE SURROUNDING THE ABUTMENT AND TO PLACE A MAGNET ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED MARCH 18, 2016. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED GRANULATION TISSUE AND INFECTION AT THE ABUTMENT SITE. SUBSEQUENTLY ON (B)(6) 2016, THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166920 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 132531

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention