MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 Implant 4mm w Abutment 12mm; Cochlear Baha Connect System

Model Number	93332
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Purulent Discharge (1812); Inflammation (1932); Impaired Healing (2378); Skin Infection (4544)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced an infection, and non-healing skin and tissue after a baha abutment removal.Subsequently, the implant was explanted on (b)(6) 2026.Reimplantation is planned but had not taken place at the time of this report.
Additional Manufacturer Narrative
Correction: the product reported in the initial mdr "[6000034-2026-01366]" which was submitted on april 21, 2026 is incorrect.The correct product is bia400 implant 4mm w abutment 12mm, not bi300 implant 4 mm.Per the clinic, the patient developed a persistent infection that had been ongoing for more than 12 months since (b)(6) 2024 (specific date not reported).The patient also experienced low grade inflammation followed by chronic discharge, tenderness, and scab formation causing frequent interruption with device use leading to the abutment removal on (b)(6) 2024.After the abutment removal, the patient experienced non healing skin/soft tissue.Subsequently, the patient was treated with oral and topical antibiotics daily; however, the issue could not be resolved leading to the decision to explant the implant screw.The implant screw was explanted on (b)(6) 2026.Reimplantation is planned but had not taken place at the time of this report.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer, and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan, and the status is updated on a monthly basis.This event is added to this monitoring.

• Brand Name: BIA400 Implant 4mm w 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: anu sundaraji ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24933858
• Report Number: 6000034-2026-01366
• Device Sequence Number: 20125803
• Product Code: MAH
• UDI-Device Identifier: 09321502022729
• UDI-Public: (01)09321502022729(10)150420(17)181130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Expiration Date: 11/30/2018
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: 150420
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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