MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	92346
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Impaired Healing (2378); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment and slight pain on palpation.Treatment with topical antibiotic (specific date and duration not reported) was unsuccessful.Additionally, the patient requested repositioning of the implant to a lower location, as the original placement interfered with the patient's hair.Subsequently, the patient underwent a revision surgery under general anesthesia on (b)(6) 2025, for an abutment removal.The implant fixture could not be removed due to firm osseointegration and was therefore left in situ and capped with a conical cover screw.A new implant site was created approximately 1 cm inferior to the original location, where a new implant fixture and abutment were placed.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 9MM
• 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: nabila zahari ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 23970773
• Report Number: 6000034-2026-00072
• Device Sequence Number: 18104205
• Product Code: LXB
• UDI-Device Identifier: 09321502019767
• UDI-Public: (01)09321502019767(10)COH1667132(17)280907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/06/2026

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: 92346
• Device Catalogue Number: 92346
• Device Lot Number: COH1667132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/05/2026
• 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: Male