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 Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss.

• 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 ; 94286555
• MDR Report Key: 6452517
• MDR Text Key: 71457686
• Report Number: 6000034-2017-00651
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/03/2017
• 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