MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93332

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

Patient Problems Impaired Healing (2378); Skin Infection (4544)

Event Date 12/04/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 5, 2023.

Event Description

Per the clinic, the patient experienced skin overgrowth.The device (both implant and abutment) was explanted on (b)(6) 2022.The patient was re-implanted with a new device in the same procedure.

Event Description

Per the clinic, it was reported that the patient experienced an infection at the implant site (date not reported).Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: the previous mdr submitted on march 01, 2023, was filed inadvertently.No infection has occurred.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• 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: 16099819
• MDR Text Key: 306677919
• Report Number: 6000034-2023-00075
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022385
• UDI-Public: (01)09321502022385(10)COH1129957(11)07312017(17)06202022
• 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,Followup
• Report Date: 04/18/2023,03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2022
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: COH1129957
• 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: 04/18/2023
• Distributor Facility Aware Date: 03/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male