MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93357
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at the abutment site.Subsequently, the patient underwent a skin revision surgery under general anesthesia (date not reported) in order to remove the overlying skin to fully expose the abutment and replace the abutment.However, during the procedure due to thick skin and the depth of the site, fixation of the new abutment to the existing fixture was difficult.Bleeding from the skin further impaired the surgical field.Bilateral skin incisions were subsequently made, to improve visualization, and the procedure was continued under microscopic guidance.The patient was then replaced with a new abutment during the same surgery successfully.

• Brand Name: BA300 ABUTMENT 12MM
• 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: 23307962
• Report Number: 6000034-2025-03786
• Device Sequence Number: 12045885
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• UDI-Public: (01)09321502033435(10)COH1511866(17)270110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100360
• 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): 10/16/2025

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 Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1511866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/16/2025
• 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 Sex: Female