MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 3.5MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 92994

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Impaired Healing (2378)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 23, 2022.

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient underwent a revision surgery under general anesthesia on (b)(6) 2022, in order to remove the abutment.

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 3.5MM
• 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: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14786002
• MDR Text Key: 294570465
• Report Number: 6000034-2022-01876
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021661
• UDI-Public: (01)09321502021661(10)168042(17)211206
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/03/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2021
• Device Model Number: 92994
• Device Catalogue Number: 92994
• Device Lot Number: 168042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 14 YR
• Patient Sex: Female