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

Model Number	8980018P3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were xrays provided to confirm the alleged event.As per reporter computerized tomography (ct) and magnetic resonance imaging (mri) images confirmed the screws were touching a nerve.It is unknown if fluoroscopy was used at time of procedure.Labeling review: warnings, cautions and precautions: potential risks identified with the use of this device system, which may require additional surgery, include neurological injury."careful preoperative planning and the use of intraoperative fluoroscopy/imaging should be utilized to help avoid spinal cord, vertebral artery, nerve root, and/or other injuries.".
Event or Problem Description
On (b)(6) 2019, patient underwent a posterior cervical spinal fusion procedure at c4/5/6 levels with no reported issue.On (b)(6) 2019, one day postoperative, the patient started to experience numbness in right upper limb.That same day the patient underwent a revision procedure where all screw sets and rods of right side at the c5 and c6 levels were removed along with a left side rod.New screws were implant on the c5 level but not c6.New screw set and rods were implanted on both sides at the c7 levels.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8735071
• Report Number: 2031966-2019-00213
• Device Sequence Number: 2540203
• Product Code: NKG
• UDI-Device Identifier: 00887517826367
• UDI-Public: 887517826367
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8980018P3
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/26/2019
• 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
• Patient Age: 64 YR