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

Model Number 93101

Device Problem Osseointegration Problem (3003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient details unavailable at the time of this report, this report is submitted on august 15, 2017.(b)(4).

Event Description

Per the clinic, the patient experienced a loss of osseointegration, subsequent to the patient experiencing pain and drainage at the at the abutment site.The patient was treated with oral antibiotics for a period of 7 days.

• 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
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6793619
• MDR Text Key: 82654839
• Report Number: 6000034-2017-01555
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021692
• UDI-Public: (01)09321502021692(10)162032(17)210107
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2021
• Device Model Number: 93101
• Device Catalogue Number: 93101
• Device Lot Number: 162032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• 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