MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92127

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced infection at the implant site and a loss of osseointegration resulting in fixture loss.The patient was treated with iv and topical antibiotics (specific date and duration not reported), however the issue did not resolved.Subsequently, the implant fixture was explanted under general anesthesia on (b)(6) 2023.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 16641477
• MDR Text Key: 312280311
• Report Number: 6000034-2023-00998
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019521
• UDI-Public: (01)09321502019521(10)93636(17)160930
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023,03/12/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 92127
• Device Catalogue Number: 92127
• Device Lot Number: 93636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Distributor Facility Aware Date: 03/12/2023
• Date Report to Manufacturer: 03/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female