MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93331
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced recurrent intermittent weeping in granulation tissue around the abutment and an infection at the abutment site.Subsequently the patient was treated with antibiotics (specific type, date and duration not reported).The patient also underwent a skin revision surgery (specific date not reported) where an ellipse of the skin around the abutment was removed.Additional information has been requested but has not been made available as of the date of this report.
Additional Manufacturer Narrative
Correction (g3): the correct manufacturer date of awareness is february 10, 2026, not february 13, 2026 as previously reported in initial mdr [6000034-2026-01145].Per the clinic, the patient also experienced skin overgrowth around the abutment.Subsequently, the abutment was removed on (b)(6) 2025.Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24573725
• Report Number: 6000034-2026-01145
• Device Sequence Number: 13069891
• Product Code: MAH
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)COH1333892(17)240904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 09/04/2024
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1333892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male