MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE PULSE SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	1881500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a confirmation radiograph scan in a navigated mis surgical case it was determined that the screws placed on the right side of the l2, l4, and l5 vertebrae were malplaced while screws on the left side were determined to be accurately placed.The malplaced screws were observed and corrected during the case.No patient injury was reported.
Additional Manufacturer Narrative
A radiographic image provided as well as an on-site representative were able to confirm the reported event.Pre-case navigational accuracy checks passed with no need for calibration.Additionally, the case prior to reported event was performed with no navigational inaccuracies.Development engineering reviewed the system's log following the case but were unable to identify an issue; the system was found to be operating as intended.The system was tested by a service engineer in the field on (b)(6)2022 and passed all applicable testing.Based on the information obtained, the root cause of the reported event cannot be determined but may be a result of line-of-sight issues between the camera and tracking arrays.Labeling review: ".Warnings, cautions and precautions: read all instructions and understand all warnings and cautions before using the system or accessories.Failure to do so may lead to serious medical consequences.Refer to the instructions for use accompanying other nuvasive products before use with the system to assure proper and safe use of these devices.If system data acquisition seems inaccurate or if the software application does not initiate or malfunctions during use, and recommended steps to restore the system are not successful, abort use of the system.The accuracy of data acquisition can be influenced by the rotation of the passive reflective array relative to the camera.Cameras should be placed such that a direct line of sight to the operative area is established." "intra-operative warnings:.Assess navigational accuracy repeatedly throughout a procedure when using a surgical navigation system.A) reconfirm accuracy by positioning the navigated instrument tip on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system.B) if the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.G.Resetting the system), do not rely on the navigation system.Reliance on data provided by a camera with an interrupted optical path may lead to inaccurate measurements.

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 15033059
• Report Number: 2031966-2022-00089
• Device Sequence Number: 6919774
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/06/2022

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: 1881500
• Was Device Available for Evaluation?: Yes
• 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: 04/08/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose