MAUDE Adverse Event Report: NUVASIVE, INC. VUEPOINT OCT SYSTEM; SPINAL INTERLAMINAL FIXATION APP

Model Number 7906308

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

On (b)(6) 2013 pt underwent posterior cervical fusion and implantation of a five level posterior cervical construct from occiput to c6.During f/u on (b)(6) 2015 to extend the construct from c6 to t2, it was discovered that the bone screws in the occipital plate had backed out.Revision surgery occurred on (b)(6) 2015 to extend the construct, but the occipital screws were not removed and the pt has solid fusion on the plate.Pt is doing well.Pt's bone integrity, activity level and compliance with post-surgical instructions over the last two years are unk.

Manufacturer Narrative

(b)(4).Radiograph was received confirming the event.There was solid fusion of the plate and the surgeon elected not to revise the occipital bone screws.The devices remain insitu.No product info was given, no product returned no further eval of the product can be completed at this time.It is unk if the pt sustained some impact or fall during the last two years.The root cause of this reported event has not been determined; no conclusion can be drawn.

• Brand Name: VUEPOINT OCT SYSTEM
• Type of Device: SPINAL INTERLAMINAL FIXATION APP
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4856776
• MDR Text Key: 5811131
• Report Number: 2031966-2015-00032
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7906308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 06/13/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR