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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Head Injury (1879); Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a loss of fixture subsequent to sustaining a head trauma (specific date not reported).The patient was reimplanted with another device under local anesthesia on (b)(6) 2026.

• 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, västergötland 43533 ; SW 43533
• MDR Report Key: 50851005
• Report Number: 6000034-2026-03367
• Device Sequence Number: 21220866
• Product Code: MAH
• UDI-Device Identifier: 09321502022729
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026
• Report Date (Section F): 09/22/2026

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: 08/31/2020
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: 176319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 09/22/2026