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 Codes	Cellulitis (1768); Pain (1994); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced chronic skin inflammation, localized cellulitis and pain around the abutments.Subsequently, the patient was placed under general anesthesia on (b)(6) 2025, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.It was also reported that the patient underwent minor skin revision using local flaps during the same surgery.

• 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: 23919405
• Report Number: 6000034-2025-04660
• Device Sequence Number: 18395388
• Product Code: MAH
• UDI-Device Identifier: 09321502022705
• UDI-Public: (01)09321502022705(10)COH888449(17)210706
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2025
• Report Date (Section F): 12/30/2025

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: 07/06/2021
• Device Model Number: 93330
• Device Catalogue Number: 93330
• Device Lot Number: COH888449
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/03/2025
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• 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 Sex: Female
• Date Report Sent to FDA: 12/30/2025