MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	18009352
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation as the were left in-situ, though the provided radiographs confirm the reported event.The patient bone quality is unknown.The patients post-operative physical activity or if a fall was experienced is unknown.Review of the provided radiographs suggest an excessively angled screw approach may be the cause or contributor to an incomplete lock engagement though no root cause could be determined.No additional investigation can be completed.Label review: ".Potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery, include.Bending, fracture or loosening of implant component(s)." ".To prevent compromising the bone-screw interface, caution should be taken not to over-torque the temporary fixation pin once it has tightened against the plate.To allow for proper utility of the locking mechanism during screw placement, use a drill-guide with the awl and/or drill to create a centered screw hole into the vertebral bodies¿" ".Bending of the nuvasive acp system is not recommended.Bending will compromise the mechanical performance of the plate and may adversely affect fit and function of the screw retaining mechanisms.If bending is unavoidable, be certain to bend the plate between the screw holes and retaining mechanisms.Inspect the plate for damage after bending." ".To allow for proper utility of the locking mechanism during screw placement, use a drill-guide with the awl and/or drill to create a centered screw hole into the vertebral bodies." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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." ".Post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
Event or Problem Description
On (b)(6) 2021 a patient underwent a three level anterior cervical discectomy fusion without a reported issue.On (b)(6) 2021 radiographs identified the rt caudal plate screw backed out post-operatively.The surgeon reported he had no issues turning the locks at all.He hasn't done many of these but we've never had any issues with the locking mechanism.Patient is asymptomatic.

• Brand Name: NUVASIVE ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE INC.; 7574 lusk blvd.; san diego CA 92121
• MDR Report Key: 12746748
• Report Number: 2031966-2021-00150
• Device Sequence Number: 11924236
• Product Code: KWQ
• UDI-Device Identifier: 00195377008510
• UDI-Public: 195377008510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203253
• 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): 09/29/2021

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: 18009352
• 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: 09/29/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 18009352.