MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93335
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Fibrosis (3167); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the abutment was electively removed under general anesthesia on (b)(6) 2024.The implanted device remains.
Event or Problem Description
Per the clinic, the patient experienced significant keloid / hypertrophic scarring / fibrosis around the abutment site and underwent a skin revision surgery to remove the excess tissue on (b)(6) 2024.

• Brand Name: BA400 ABUTMENT 10MM
• 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: 20554439
• Report Number: 6000034-2024-03674
• Device Sequence Number: 14225181
• Product Code: MAH
• UDI-Device Identifier: 09321502022750
• UDI-Public: (01)09321502022750(10)194781(17)250827
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024
• Report Date (Section F): 12/27/2024

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: 08/27/2025
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 194781
• 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: 12/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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 Age: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/27/2024