MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB Flange Fixture ST 3mm w. Baha Abutment; Cochlear Baha Connect System

Model Number	90480
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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 device was explanted on (b)(6) 2025; under general anesthesia due to abutment fell out.During the procedure, the patient was converted to transcutaneous osia implant system.
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: Flange Fixture ST 3mm w. Baha Abutment
• 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: 50536368
• Report Number: 6000034-2026-03075
• Device Sequence Number: 6051239
• Product Code: LXB
• UDI-Device Identifier: 09321502014298
• UDI-Public: (01)09321502014298(10)601818(17)090801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K955713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• 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 Expiration Date: 08/01/2009
• Device Model Number: 90480
• Device Catalogue Number: 90480
• Device Lot Number: 601818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• 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: Female