MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93330

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); Fluid Discharge (2686); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 22, 2022.

Event Description

Per the clinic, the patient experienced an infection (b)(6) (treatment unknown) and drainage at the implant site.Initially the abutment was removed but the infection did not resolve.The device was explanted on (b)(6) 2022.It is unknown if there are plans to re-implant the patient with another device.

Event Description

Per the clinic, the patient was placed under general anaesthesia in order to have the implant explanted.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 8MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 14179277
• MDR Text Key: 289865735
• Report Number: 6000034-2022-01119
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022705
• UDI-Public: (01)09321502022705(10)134810(17)180430
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022,05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93330
• Device Catalogue Number: 93330
• Device Lot Number: 134810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2022
• Distributor Facility Aware Date: 05/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female