MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA ATTRACT SYSTEM

Model Number	92129
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed a staphylococcus aureus infection and subsequently the device has been explanted on (b)(6) 2025.There are no plans to reimplant the patient with a new device as of the date of this report.

• Brand Name: BI300 IMPLANT 4 MM
• 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: 23355538
• Report Number: 6000034-2025-03769
• Device Sequence Number: 8871517
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1129966(17)220711
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025
• Report Date (Section F): 10/22/2025

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: 07/11/2022
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH1129966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/29/2025
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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: 10/22/2025