MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); Skin Infection (4544)
Date of Event	12/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on january 5, 2023.
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth.The device (both implant and abutment) was explanted on (b)(6) 2022.The patient was re-implanted with a new device in the same procedure.
Event or Problem Description
Per the clinic, it was reported that the patient experienced an infection at the implant site (date not reported).Additional information has been requested but it has not been made available as of the date of this report.
Event or Problem Description
Correction: the previous mdr submitted on march 01, 2023, was filed inadvertently.No infection has occurred.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 16099819
• Report Number: 6000034-2023-00075
• Device Sequence Number: 15009646
• Product Code: MAH
• UDI-Device Identifier: 09321502022385
• UDI-Public: (01)09321502022385(10)COH1129957(11)07312017(17)06202022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2023
• Report Date (Section F): 04/18/2023

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: 06/20/2022
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: COH1129957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/01/2023; 04/18/2023
• 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: 76 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/18/2023