MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93329
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on february 21, 2023.
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth.Subsequently, the patient was placed under general anesthesia on (b)(6) 2019 in order to explant the device and underwent a skin revision surgery to remove excess skin.It is also reported that the patient was treated with topical and oral antibiotics (date and duration not reported).

• Brand Name: BIA400 IMPLANT 4MM W 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16406620
• Report Number: 6000034-2023-00558
• Device Sequence Number: 6410074
• Product Code: MAH
• UDI-Device Identifier: 09321502022699
• UDI-Public: (01)09321502022699(10)149216(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: 10/31/2018
• Device Model Number: 93329
• Device Catalogue Number: 93329
• Device Lot Number: 149216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female