MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93336
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a granulation tissue around the abutment.Subsequently, the patient was placed under general anesthesia on (b)(6) 2026; in order to remove the abutment and replaced during the same surgery.

• Brand Name: BA400 ABUTMENT 12MM
• 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: 25010896
• Report Number: 6000034-2026-01545
• Device Sequence Number: 18741796
• Product Code: MAH
• UDI-Device Identifier: 09321502022729
• UDI-Public: (01)09321502022729(10)COH1606394(17)280117
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026
• Report Date (Section F): 04/28/2026

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 Model Number: 93336
• Device Catalogue Number: 93336
• Device Lot Number: COH1606394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• 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: 17 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/28/2026