MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93329
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.The patient was reimplanted with another cochlear device on (b)(6) 2022.

• Brand Name: BIA400 IMPLANT 4MM 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
• MDR Report Key: 14483798
• Report Number: 6000034-2022-01504
• Device Sequence Number: 5321464
• Product Code: MAH
• UDI-Device Identifier: 09321502022699
• UDI-Public: (01)09321502022699(10)COH1267462(17)231023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2022
• Report Date (Section F): 05/24/2022

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: 10/23/2023
• Device Model Number: 93329
• Device Catalogue Number: 93329
• Device Lot Number: COH1267462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2022
• Date Report to Manufacturer: 05/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2022
• 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: 05/24/2022