MAUDE Adverse Event Report: NUVASIVE INC VUEPOINT II SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Device Problem Missing Information (4053)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation nor were x-rays films provided.Multiple attempts have been made to try and obtain additional patient and/or event information with no further response.

Event Description

Received information stating patient underwent a revision occipital procedure.At this time it unknown why the procedure was performed as no additional information was able to be provided.

• Brand Name: VUEPOINT II SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 74575 lusk blvd; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 9582800
• MDR Text Key: 183096822
• Report Number: 2031966-2020-00006
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K180198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention