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

Model Number	93335
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Impaired Healing (2378); Skin Inflammation/ Irritation (4545)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth and inflammation on the abutment.Subsequently, the patient was placed under general anesthesia on (b)(6) 2023 in order to remove the abutment.

• 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: 17168676
• Report Number: 6000034-2023-01899
• Device Sequence Number: 17785664
• Product Code: MAH
• UDI-Device Identifier: 09321502022750
• UDI-Public: (01)09321502022750(10)179507(17)231001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2023
• Report Date (Section F): 06/21/2023

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: 10/01/2023
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 179507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2023
• Date Report to Manufacturer: 05/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2023
• 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: 16 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/21/2023