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

Device Problems Mechanical Problem (1384); Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 04/09/2013

Event Type  malfunction  

Event Description

Initial posterior cervical fusion surgery was performed on (b)(6) 2013 and consisting of a posterior cervical construct from the occiput to c7.During (b)(6) 2013, the occipital bone screws reportedly began to back out.Progressive screw back out was observe via radiographs in (b)(6) 2013.Further screw back out was noted and revision surgery occurred (b)(6) 2014.Patient is asymptomatic.Patient's bone quality is in unknown.Patient's activity level is unknown.Patient compliance with post surgical instructions is unknown.

Manufacturer Narrative

(b)(4) radiographs were received depicting the reported event.Fusion of the vertical bodies has occurred.The revision involved the removal of the posterior occipital portion of the construct on (b)(6) 2014.This portion was retained by the hospital.Patient is doing well post-revision.The remainder of the posterior construct remains implanted.The root cause of this reported event has not been determined; no conclusion can be drawn.Labeling review notes the following: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.".

• Brand Name: VUEPOINT OCT SYSTEM
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 3855927
• MDR Text Key: 21808602
• Report Number: 2031966-2014-00019
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• 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
• Distributor Facility Aware Date: 02/28/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/28/2014
• 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: 79 YR
• Patient Weight: 121