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	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the confirmation scan of a navigated l4 to l5 anterior lumbar interbody fusion procedure the surgeon noted that the left and right screws placed on l4 were malplaced.The surgeon noted that the navigation was presenting 2mm proud and 3mm caudal to the actual placement.The screws were removed, the patient was re-scanned, and the screws were replaced correctly under navigation.
Additional Manufacturer Narrative
An on-site representative was able to confirm the reported event.Pre-case navigational accuracy checks passed.Post-case accuracy checks passed with no differences seen from the pre-case accuracy check.Additionally, the tracking arrays were re-registered and accuracy of instruments was checked four (4) times but no cause could be determined.Development engineering reviewed the system's log following the case including the re-registration accuracy tests but were unable to identify a cause.The system was tested by a service engineer in the field on 20apr2022 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 inaccurate tracking array registration at the beginning of the case due to hospital lighting factors.No additional investigation can be completed.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: 15033074
• Report Number: 2031966-2022-00091
• Device Sequence Number: 6920356
• 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): 05/12/2022

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: 04/14/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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