MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93335
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced repeated skin infections at the abutment site (date not reported).Subsequently, the patient underwent abutment removal procedure on (b)(6) 2025.During the same procedure, the patient was re-implanted with a transcutaneous osia implant system under general anesthesia at the new implant site.

• Brand Name: BA400 ABUTMENT 10MM
• 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: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 23080897
• Report Number: 6000034-2025-03471
• Device Sequence Number: 9738163
• Product Code: MAH
• UDI-Device Identifier: 09321502022750
• UDI-Public: (01)09321502022750(10)140078(17)180228
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 02/28/2018
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 140078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 13 YR
• Patient Sex: Female