MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR VISTAFIX VXI300 IMPLANT 4MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 93101

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on 07 april 2021.

Event Description

Per the clinic, the patient experienced a loss of ossseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in implant loss.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2021.

Manufacturer Narrative

Corrections have been made to b5 (description of event - date of this report), d4 (catalog no and lot no updated), d9 (device available for evaluation), g1 (manufacturing site), h3 (device evaluated by manufacturer), h6 (clinical code & impact code).This report is submitted on (b)(6) 2021.

• Brand Name: COCHLEAR VISTAFIX VXI300 IMPLANT 4MM
• Type of Device: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 11625858
• MDR Text Key: 244158837
• Report Number: 6000034-2021-01042
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021722
• UDI-Public: (01)09321502021722(10)159688(17)190630
• Combination Product (y/n): N
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93101
• Device Catalogue Number: 93101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention