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	Erythema (1840); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced multiple irritations, inflammation and infections at implant site.Subsequently, the patient was treated with oral antibiotics (specific date and duration not reported).After a period of time, the patient experienced redness, swelling and pain around the abutment tissues and was prescribed with oral antibiotics (specific date and duration not reported).Then, skin revision surgery was done with chemical cautery under local anesthesia however, the issue did not resolve.Subsequently, the device was explanted on (b)(6) 2026.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

• 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: ehswarakali sadasivam ; unit ug-1 vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50801403
• Report Number: 6000034-2026-03209
• Device Sequence Number: 8644166
• Product Code: MAH
• UDI-Device Identifier: 09321502022729
• 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 Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 93332
• Device Catalogue Number: 93332
• Device Lot Number: COH1628584
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/17/2026
• 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