BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 23786926 · Received December 12, 2025

    Report

    Report Number
    6000034-2025-04446
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 12, 2025
    Report Date
    April 23, 2026
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D2: THE CORRECT PRODUCT CODE IS LXB; NOT MAH AS PREVIOUSLY REPORTED. CORRECTION G4: THE CORRECT PMA/510 (K) IS K955713; NOT K121317 AS PREVIOUSLY REPORTED. PER THE CLINIC, ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA TO REMOVE THE KELOID SCAR. DURING THE SAME SURGICAL PROCEDURE, THE ABUTMENT SCREW THAT HAD BEEN COVERED BY THE KELOID WAS REMOVED; HOWEVER, THE INTERNAL FIXTURE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH AROUND THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT BAHA WAS REMOVED UNDER GENERAL ANAESTHESIA ON (B)(6) 2025 AND A NEW 4MM IMPLANT WITH 14MM ABUTMENT WAS PLACED AT A NEW SITE AS THERE WAS A KELOID SCARE OVER THE ORIGINAL IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2712258 ASKU COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention| H