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

Model Number VIX300

Device Problem Loss of Osseointegration (2408)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient and initial implantation details unavailable at the time of this report, this report is filed on september 27, 2016.(b)(4).Implanted device remains.

Event Description

Per the clinic, the patient experienced a loss of osseointegration.Clinical management of the patient is ongoing.

Manufacturer Narrative

Correction: there was no loss of osseointegration.It was reported by the clinic that osseointegration took longer than expected; however, eventually did osseointegrate to the bone.The implanted device remains insitu.

• Brand Name: COCHLEAR VISTAFIX
• Type of Device: FZE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111
• Manufacturer Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 2 9428 655
• MDR Report Key: 5978913
• MDR Text Key: 55667495
• Report Number: 6000034-2016-01938
• Device Sequence Number: 1
• Product Code: FZE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIX300
• Device Catalogue Number: 93100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/30/2016
• Date Manufacturer Received: 01/11/2017
• 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