BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA400 ABUTMENT 8MM

    MDR report key: 13148457 · Received January 4, 2022

    Report

    Report Number
    6000034-2022-00075
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    December 14, 2021
    Report Date
    July 13, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JANUARY 4, 2022.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS MDR SUBMITTED ON JANUARY 4, 2022 WAS FILED INADVERTENTLY. NO DEVICE EXPLANTATION HAS OCCURRED. THE SUSPECTED DEVICE (D1 TILL D4) WAS FILED INADVERTENTLY IN THE PREVIOUS REPORT, THE CORRECT PRODUCT SHOULD BE BA400 ABUTMENT 8MM ; PRODUCT CODE : MAH ; MODEL/CATALOG : 93334. THE PREMARKET IDENTIFICATION WAS FILED INADVERTENTLY IN THE PREVIOUS REPORT, THE CORRECT PRE-MARKET IDENTIFICATION SHOULD BE K121317. PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION OVER THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY UNDERWENT SKIN REVISION SURGERY (SPECIFIC DATE NOT REPORTED) TO REMOVE THE SKIN OVER THE ABUTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THIS REPORT IS SUBMITTED ON JULY 04, 2022.

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA DURING THE ABUTMENT REMOVAL PROCEDURE ON (B)(6) 2021. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THE REPORTED ADVERSE EVENT IS ASSOCIATED WITH A RETURNED DEVICE; HOWEVER, THE PROVIDED CLINICAL INFORMATION WAS REVIEWED BY THE MANUFACTURER AND NO SPECIFIC DEVICE ANALYSIS IS DEEMED NECESSARY AT THIS TIME. PREVIOUS PRODUCT EXAMINATIONS HAVE NOT SHOWED ANY RELATIONSHIP BETWEEN A PRODUCT GEOMETRICAL DEVIATION AND THE REPORTED CLINICAL COMPLICATION. ADDITIONALLY, THERE ARE NO INDICATIONS THAT A PRODUCT FAILURE HAS CONTRIBUTED TO THE REPORTED ISSUE. ADVERSE SKIN REACTIONS AROUND THE BAHA ABUTMENT, RANGING FROM SLIGHT REDNESS TO INFECTED TISSUE, ARE COMMON COMPLICATIONS WITH BAHA IMPLANTS, AND CAN OCCUR AT ANY TIME FOLLOWING IMPLANTATION. THE REPORT FREQUENCY FOR THESE COMPLICATIONS IS BEING MONITORED UNDER CBAS COMPLAINT AND MEDICAL DEVICE REPORTING DATA MONITORING PLAN AND THE STATUS IS UPDATED ON A MONTHLY BASIS. THIS EVENT IS ADDED TO THIS MONITORING. THIS REPORT IS SUBMITTED ON AUGUST 05, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021 IN ORDER FOR THE PATIENT TO UPGRADE TO A DIFFERENT IMPLANT COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365772 BA400 ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93334 NI
    528413 BA400 ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93334 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention