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 Problem Hearing Impairment (1881)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 11, 2019, by cochlear ltd.

Event Description

Per the clinic, the patient experienced a loss of osseointegration due to a fall.The implant / abutments were replaced (date not reported).

• 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: 8778902
• MDR Text Key: 150677492
• Report Number: 6000034-2019-01174
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2019,06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2019
• Event Location: Home
• Date Report to Manufacturer: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention