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

Model Number 8975312

Device Problems Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 04/17/2014

Event Type  Other  

Event Description

Initial posterior cervical fixation surgery was on (b)(6) 2013 in which 6 lateral mass screws and 4 pedicle screws were placed bilaterally c5 to t4.On (b)(6) 2014, it was reported that 4 lateral mass screws disassociated from the bone.Pt's activity level is unk.Pt compliance with post surgical instructions is unk.Pt noted to have fallen prior to event discovery.

Manufacturer Narrative

(b)(4).Ct scan of the event were received, but were inconclusive.Pt underwent revision surgery to replace lateral mass screws and extend construct to c4.Pt is reportedly doing well post revision surgery.No screws have been returned.They were discarded by the hosp and no further eval of the product can be completed at this time.The root cause of this reported event has not been determined, no conclusion can be drawn, but the pt's radiation treatment for metastatic liver cancer may have caused or contributed to the poor bone quality.

• 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: 3855551
• MDR Text Key: 17281638
• Report Number: 2031966-2014-00032
• Device Sequence Number: 1
• Product Code: KWP
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8975312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2014
• 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