MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92130
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth on the abutment.Subsequently, the patient underwent a skin revision surgery to remove the excess skin under general anesthesia (specific date not reported).The implanted device remains.

• Brand Name: BA300 ABUTMENT 6MM
• 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: 16705415
• Report Number: 6000034-2023-01104
• Device Sequence Number: 17547140
• Product Code: LXB
• UDI-Device Identifier: 09321502019552
• UDI-Public: (01)09321502019552(10)COH200160(17)160130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2023
• Report Date (Section F): 04/10/2023

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: 01/30/2016
• Device Model Number: 92130
• Device Catalogue Number: 92130
• Device Lot Number: COH200160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2023
• Date Report to Manufacturer: 03/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2023
• 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 Sex: Male
• Date Report Sent to FDA: 04/10/2023