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)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury

• 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; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): Cochlear Bone Anchored Solutions AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: amalia azman ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50657600
• Report Number: 6000034-2026-03155
• Device Sequence Number: 9424746
• Product Code: LXB
• UDI-Device Identifier: 09321502019767
• UDI-Public: 09321502019767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/07/2026
• 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