MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BA400 Abutment 12mm; Cochlear Baha Connect System

Model Number	93336
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Head Injury (1879); Implant Pain (4561); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient reportedly sustained a head trauma, resulting in inward displacement of the abutment and implant fixture.The patient subsequently experienced pain and swelling at the abutment site, along with skin overgrowth around the abutment.On (b)(6) 2026, the patient underwent a procedure under local anesthesia during which the abutment was removed and the epithelium overlying the implant was debrided.There are plans to convert the patient to a transcutaneous osia implant system following complete healing; but had not taken place at the time of this report.Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BA400 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: amalia azman ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50024224
• Report Number: 6000034-2026-02851
• Device Sequence Number: 9662510
• Product Code: MAH
• UDI-Device Identifier: 09321502022767
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• 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): 07/27/2026

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: 05/29/2024
• Device Model Number: 93336
• Device Catalogue Number: 93336
• Device Lot Number: 184671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• 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