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	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (specific date not reported).There are no plans to re-implant the patient with a new device as of the date of this report.The patient was subsequently fitted with the device on a soundarc on (b)(6) 2026.
Additional Manufacturer Narrative
Correction: the patient's date of birth is (b)(6) 1946, not (b)(6) 1946, as previously reported.The reporter's clinic name has been updated to royal victorian eye & ear hospital.

• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24451522
• Report Number: 6000034-2026-00691
• Device Sequence Number: 21158274
• Product Code: MAH
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)COH1425615(17)251214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/03/2026

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: 12/14/2025
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1425615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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