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

Model Number	7906340
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No films were received that corroborate the reported event, however, clinical summary provided notes that the clinical goals of fixation and cervical alignment were preserved despite the component separation.The patient was monitored for 24 months without clinical complications.Review of labeling notes: "potential risks identified with the use of this system, which may require additional surgery, include:bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, fracture of the vertebra,.".
Event or Problem Description
On (b)(6) 2011 a (b)(6) year-old female patient with significant prior surgical history received segmental posterior fixation from occiput - c2 as well as c3-t3.6-8 weeks after index surgery, the fixation rod separated from the occipital plate.The detachment of the rod from the occiput was not repaired.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6481794
• Report Number: 2031966-2017-00032
• Device Sequence Number: 19096256
• Product Code: NKG
• UDI-Device Identifier: 00887517184856
• UDI-Public: 00887517184856
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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: Physician
• Device Model Number: 7906340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR