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	Skin Infection (4544)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed an infection and subsequently the device was explanted on (b)(6) 2026.There are no plans to reimplant the patient with a new device as of the date of this report.Additional information has been requested but has not been made available as of the date of this report.
Event or Problem Description
Per the clinic, the patient was treated with oral antibiotics on (b)(6) 2025, administered three times daily for 5 days.The abutment was also reportedly removed on the same date.Subsequently, on (b)(6) 2025, the patient was prescribed antiseptic treatment and topical antibiotics, to be applied twice daily for 14 days.Following the appointment on (b)(6) 2025, the patient received an additional course of oral antibiotics (specific duration not reported).During the explant surgery on (b)(6) 2026, the surgeon encountered a small maxillofacial screw, which was drilled out and removed.No infection was reported following the explant 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: 24580051
• Report Number: 6000034-2026-00883
• Device Sequence Number: 9233725
• Product Code: MAH
• UDI-Device Identifier: 09321502022705
• UDI-Public: (01)09321502022705(10)COH1378762(17)250324
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Expiration Date: 03/24/2025
• Device Model Number: 93330
• Device Catalogue Number: 93330
• Device Lot Number: COH1378762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• Supplement 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 Sex: Female
• Date Report Sent to FDA: 04/29/2026