COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM 93101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-03 for COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM 93101 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[71457686] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[71457687] Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2017-00651
• MDR Report Key: 6452517
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2017-04-03
• Date of Report: 2017-03-13
• Date Mfgr Received: 2017-03-13
• Date Added to Maude: 2017-04-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SUJEEWA WIJESINGHE
• Manufacturer Street: 1 UNIVERSITY AVENUE
• Manufacturer City: MACQUARIE UNIVERSITY, NSW 2109
• Manufacturer Country: AS
• Manufacturer Postal: 2109
• Manufacturer Phone: 94286555
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COCHLEAR? VISTAFIX? VXI300 IMPLANT 4MM
• Generic Name: COCHLEAR BAHA VISTAFIX SYSTEM
• Product Code: FZE
• Date Received: 2017-04-03
• Returned To Mfg: 2017-03-31
• Model Number: 93101
• Catalog Number: 93101
• Lot Number: UNKNOWN
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Address: KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-04-03