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

Model Number	8976240
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No films have been received confirming the reported event.Review of surgical case records indicate components from two product systems were mixed.This may have been a causal factor in the reported event.No information related to compliance with post-operative care instructions or patient fall/impacts has been received.Labeling review: "compatibility: do not use vuepoint oct system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.All implants should be used only with the appropriately designated instrument (reference surgical technique).Instruments and implants are not interchangeable between systems.".
Event or Problem Description
Following implantation of a posterior cervical fixation construct on (b)(6) 2015, fracture of a rod and a keel plate screw loosening was reported.No patient injury has been reported.Revision of the construct was reported to have occurred.

• Brand Name: NUVASIVE 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: 5368571
• Report Number: 2031966-2015-00095
• Device Sequence Number: 776168
• Product Code: NKG
• UDI-Device Identifier: 00887517137562
• UDI-Public: 00887517137562
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician

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: 8976240
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention