MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93330
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at the abutment site.As a result, the abutment was removed and replaced under general anaesthesia on (b)(6) 2026.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 8MM
• 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: 25030092
• Report Number: 6000034-2026-01605
• Device Sequence Number: 10127017
• Product Code: MAH
• UDI-Device Identifier: 09321502022705
• UDI-Public: (01)09321502022705(10)COH1770565(17)290905
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026
• Report Date (Section F): 04/29/2026

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: 93330
• Device Catalogue Number: 93330
• Device Lot Number: COH1770565
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• 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: 58 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/29/2026