MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93333
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient underwent revision surgery under general anesthesia on (b)(6) 2022 in order to remove the excess skin and replace the abutment.The implanted device remains.

• Brand Name: BA400 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: 14332686
• Report Number: 6000034-2022-01273
• Device Sequence Number: 5199060
• Product Code: MAH
• UDI-Device Identifier: 09321502022736
• UDI-Public: (01)09321502022736(10)144528(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2022
• Report Date (Section F): 05/09/2022

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: 10/31/2018
• Device Model Number: 93333
• Device Catalogue Number: 93333
• Device Lot Number: 144528
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2022
• 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: 11 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/09/2022