MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92346
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced infection at the implant site and a loss of osseointegration resulting in fixture loss.The patient was treated with oral antibiotics (specific date and duration not reported).Additional information has been requested but has not been made available as of the date of this report.
Event or Problem Description
Per the clinic, the patient underwent skin revision surgery to excise the excess skin (specific date not reported).
Event or Problem Description
Per the clinic, the patient underwent silver nitrate cauterization in order to remove excess skin (specific date not reported).

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 9MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 18167901
• Report Number: 6000034-2023-03934
• Device Sequence Number: 5788489
• Product Code: MAH
• UDI-Device Identifier: 09321502019767
• UDI-Public: (01)09321502019767(10)1563387(17)270718
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 03/19/2024
• 2 Devices were Involved in the Event: 1 2

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: 92346
• Device Catalogue Number: 92346
• Device Lot Number: COH1563387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2024
• Date Report to Manufacturer: 02/21/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/26/2023; 03/19/2024
• 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: 03/19/2024