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

Model Number 8980018P3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Numbness (2415)

Event Date 05/31/2019

Event Type  Injury  

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 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
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 8735071
• MDR Text Key: 149209850
• Report Number: 2031966-2019-00213
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00887517826367
• UDI-Public: 887517826367
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8980018P3
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR