MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BIA300 Implant 4mm w Abutment 9mm; Cochlear Baha Connect System

Model Number	92346
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient was experienced the raise of granulation tissue and the abutment was buried.Subsequently, on (b)(6) 2026; the patient underwent skin revision procedure to trim the granulation tissue and the abutment was replaced.
Additional Manufacturer Narrative
The reported adverse event is associated with a product that was not returned or was not made available for analysis.The manufacturer investigation was based on the available clinical information.The reported issue is a known medical complication, and no specific device analysis is deemed necessary at this time.

• Brand Name: BIA300 Implant 4mm w Abutment 9mm
• 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: shalini rajandran krishnan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50111540
• Report Number: 6000034-2026-02786
• Device Sequence Number: 21512696
• Product Code: LXB
• UDI-Device Identifier: 09321502019767
• UDI-Public: (01)09321502019767(10)COH1667132(17)280907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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 Model Number: 92346
• Device Catalogue Number: 92346
• Device Lot Number: COH1667132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/03/2026
• 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: Unknown