MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE VUEPOINT II OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	8976412
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation as product is still in-situ.Per surgeon's prerogative no revision surgery currently planned.No radiographs were provided.It is unknown if a torque device was utilized or hand tightened.The root cause cannot be determined as insufficient information was provided, though review of the reported information and similar complaints suggests insufficient torque applied.No additional investigation can be completed.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.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." ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure." ".Compatibility: 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
On (b)(6) 2021 an occipital case was conducted.On (b)(6) 2021 during a follow-up it was discovered that screws pulled out of the occipital plate.No revision surgery currently planned.No patient injury reported.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11585801
• Report Number: 2031966-2021-00046
• Device Sequence Number: 4296992
• Product Code: NKG
• UDI-Device Identifier: 00887517402394
• UDI-Public: 887517402394
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: Health Professional
• Device Model Number: 8976412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1