MAUDE Adverse Event Report: NUVASIVE, INC VUEPOINT II OCT SYSTEM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	8970000
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the radiograph is consistent with the reported event.The lock screw has loosened.There is no plan for revision surgery at this time.Implant remains in-situ.No further evaluation 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.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.".
Event or Problem Description
On (b)(6) 2016 a (b)(6) male patient underwent a procedure at c3-t1.At 12 week follow up the patient reported a "clicking" sound that was verified by radiograph as a post-operative lock screw loosening at the t1 disc level.There are no plans for revision.No patient injury reported.

• Brand Name: VUEPOINT II OCT SYSTEM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6156408
• Report Number: 2031966-2016-00089
• Device Sequence Number: 938152
• Product Code: NKG
• UDI-Device Identifier: 00887517397133
• UDI-Public: 00887517397133
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2016

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
• Operator of Device: No Information
• Device Model Number: 8970000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR