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

Device Problems Failure To Adhere Or Bond (1031); Mechanical Problem (1384); Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Posterior cervical spinal fusion (c4-c7) was performed in (b)(6) 2014 to treat fracture dislocation of the cervical spine.In (b)(6) 2014, the head of left c4 lateral mass screw had disassociated from shank and right c4/c5 lateral mass screws had backed out.Surgical revision is scheduled for (b)(6) 2014.Pt has severe back pain.Pt's bone quality is unk.Pt's activity level is unk.Pt compliance with post surgical instructions is unk.

Manufacturer Narrative

(b)(4).Multiple attempts have been made to gain add'l info.No radiographs confirming the event have been received.The devices were not returned and no further eval of the product can be completed at this time.It is unk if the pt sustained some impact or fall.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 ORTHOSIS
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd; san diego, CA 92121 ; 8589093347
• MDR Report Key: 3982788
• MDR Text Key: 4748743
• Report Number: 2031966-2014-00040
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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: 05/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2014
• 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 Outcome(s): Required Intervention