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

Model Number 7906000

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned and could not be evaluated.Complaint confirmed by provided radiographs.Patient post-operative physical activity is unknown.Review of the reported event suggests insufficient torque or possible locked down on uneven or unreduced rod torque handle used in case tested within normal limits so the root cause cannot be determined at this time.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." ".Patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Post-operative warnings: post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".

Event Description

On (b)(6) 2021 a posterior stabilization procedure was performed at c3 ¿ t1 right, c4-t1 left and no screw was placed in c3 right side.During a check-up it was discovered via radiographs that the set screws loosened and the rod loosened from the screws at t1 on both sides.On (b)(6) 2021 a revision surgery was performed where 2 new rods and set screws were installed.

Manufacturer Narrative

The device's were received by nuvasive and the complaint was confirmed.The root cause of the issue was determined to be an unintended procedural error related to insufficient rod reduction and normalization during lock screw placement, which can be the consequence of surgical technique but may be the result of anatomical characteristics of the patient.No additional investigation required.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." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "post-operative warnings: post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11407882
• MDR Text Key: 246678999
• Report Number: 2031966-2021-00037
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 88751783668
• UDI-Public: 88751783668
• Combination Product (y/n): N
• PMA/PMN Number: K180198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7906000
• Device Lot Number: SA4856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7906000
• Patient Age: 62 YR