MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BIM400 Implant Magnet; Cochlear Baha Attract System

Model Number	93550
Medical Device Problem Codes	Expulsion (2933); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Skin Infection (4544)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced infection with an open wound at implant site and extrusion of the device.The patient was treated with antibiotics (specific type, date and duration not reported), subsequently, the implant magnet was explanted on (b)(6), 2026.It is unknown if there are plans to reimplant the patient as of the date of this report.

• Brand Name: BIM400 Implant Magnet
• Common Device Name: Cochlear Baha Attract System
• Manufacturer (Section D): Cochlear Bone Anchored Solutions AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 50564940
• Report Number: 6000034-2026-03042
• Device Sequence Number: 9927697
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

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: 09/08/2026
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Device Lot Number: 159891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 09/02/2026