MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93334
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the surgeon, the patient experienced a weight loss resulting in the abutment being more obvious, so a shorter abutment was placed under a general anaesthetic on (b)(6) 2023.The implant remains in-situ.
Additional Manufacturer Narrative
This report is submitted on jun 6, 2023.

• Brand Name: BA400 ABUTMENT 12MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvigen 14; molnlycke, 435 3 3; AS 435 33
• MDR Report Key: 17066731
• Report Number: 6000034-2023-01757
• Device Sequence Number: 6673501
• Product Code: MAH
• UDI-Device Identifier: 09321502022385
• UDI-Public: (01)09321502022385(10)COH1105156(11)10082014
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2023
• Report Date (Section F): 06/06/2023

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 Model Number: 93334
• Device Lot Number: 182352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/15/2023
• Date Report to Manufacturer: 05/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2023
• 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: Female
• Date Report Sent to FDA: 06/06/2023