MAUDE Adverse Event Report: Cochlear Bone Anchored Solutions AB BIA300 Implant 3mm w Abutment 6mm; Cochlear Baha Connect System

Model Number	92126
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin overgrowth at the baha abutment site, which prevented attachment of the baha.Treatment with steroid cream was unsuccessful.Subsequently, the patient underwent revision surgery to remove the excess skin, and the granulation tissue was debrided on (b)(6) 2026.The existing abutment was then removed and replaced with a new 10 mm abutment.The topical antibiotics were given intra-operatively during the revision surgery.And a healing cap was placed.

• Brand Name: BIA300 Implant 3mm 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50705712
• Report Number: 6000034-2026-03212
• Device Sequence Number: 10057180
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 92126
• Device Catalogue Number: 92126
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• 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