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

Model Number	18008317
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, an anterior cervical discectomy and fusion was performed at c3/6.On (b)(6) 2021, it was discovered that a screw backed out.There is no patient injury reported and no revision surgery is planned.
Additional Manufacturer Narrative
No product was returned as product is still in-situ.Radiographs provided confirm the complaint.Patient post-op physical activity and bone quality are unknown.It is unknown if the patient suffered a fall.Though no root cause can be determined review of the reported information suggests incomplete screw advancement into lock feature, excessive angulation, or incomplete lock engagement are all possible cause or contributors.No additional investigation can be completed.Labeling review: "preoperative warning: patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "warnings, cautions and precautions: 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." "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 components." "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 ensure 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.".

• Brand Name: NUVASIVE ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13153847
• Report Number: 2031966-2022-00001
• Device Sequence Number: 5479377
• Product Code: KWQ
• UDI-Device Identifier: 00887517065179
• UDI-Public: 887517065179
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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: 18008317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 18009460
• Patient Sex: Prefer Not To Disclose