MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93333
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient was placed under general anesthesia on (b)(6) 2025 for a procedure to remove the abutment due to pain and performance decrement.The internal fixture remains.

• Brand Name: BA400 ABUTMENT 6MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 24033479
• Report Number: 6000034-2026-00237
• Device Sequence Number: 10482890
• Product Code: MAH
• UDI-Device Identifier: 09321502022736
• UDI-Public: (01)09321502022736(10)184597(17)240614
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026
• Report Date (Section F): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/14/2024
• Device Model Number: 93333
• Device Catalogue Number: 93333
• Device Lot Number: 184597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/17/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/12/2026