MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BA300 Abutment 12mm; Cochlear Baha Connect System

Model Number	93357
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.The patient underwent revision surgery on (b)(6) 2026, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the surrounding granulation tissue was excised under general anesthesia, the baha abutment was removed, and an osia implant was placed on the existing internal fixture.

• Brand Name: BA300 Abutment 12mm
• 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: jia xuan thien ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50537559
• Report Number: 6000034-2026-03080
• Device Sequence Number: 12253087
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• 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): 09/01/2026

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: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1578699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• 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