MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA VISTAFIX SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection (suppuration) at the abutment site (specific date not reported).Subsequently, the patient was treated with oral antibiotics and injectable medication (specific date and duration not reported).

Manufacturer Narrative

This report is submitted on (b)(6) 2024.

Manufacturer Narrative

Correction: the previous mdr submitted on february 21, 2024 was filed inadvertently.No explantation has occurred.This report is submitted on march 22, 2024.

Manufacturer Narrative

Correction: the previous mdr submitted on february 07, 2024 was filed inadvertently.The injectable medication (epinephrine) is not reportable.It was also reported that the device was explanted on (b)(6) 2024.This report is submitted on february 21, 2024.

• Brand Name: NI
• Type of Device: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18657005
• MDR Text Key: 334722631
• Report Number: 6000034-2024-00581
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male