MAUDE Adverse Event Report: NUVASIVE, INC. 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	02/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a posterior fixation procedure was performed utilizing the pulse system navigation for pedicle screw placement.After a pedicle screw was inserted at an unknown spine level, a confirmation scan was conducted and found the screw was placed more medial than intended.The screw was removed and the same screw was repositioned in the correct orientation using a freehand technique.Pulse system navigation was not used for the remainder of the procedure.Following the procedure, a system accuracy check was performed and the system was found to be calibrated appropriately with no inaccuracy.No patient impact was reported as a result of the event.
Additional Manufacturer Narrative
The investigation is in progress.Upon completion of the investigation, a supplemental report will be submitted.
Event or Problem Description
It was reported that a posterior fixation procedure was performed utilizing the pulse system navigation for pedicle screw placement.After a pedicle screw was inserted at an unknown spine level, a confirmation scan was conducted and found the screw was placed more medial than intended.The screw was removed and the same screw was repositioned in the correct orientation using a freehand technique.Pulse system navigation was not used for the remainder of the procedure.Following the procedure, a system accuracy check was performed and the system was found to be calibrated appropriately with no inaccuracy.No patient impact was reported as a result of the event.
Additional Manufacturer Narrative
Per the initial reporter, following the case, the system's navigational accuracy was tested and found to be operating as intended with no issues.The system logs were subsequently exported and evaluated.A review of the system logs was unable to identify any issue related to the reported event as the system was found to be operating as designed.The system logs also indicated the user had connected to the imaging system multiple times and that the chosen dicom was selected three minutes after the read from network.Although a definitive cause cannot be determined, these two events indicate potential network issues at the customer site, which may have resulted in a communication delay.As a potential result of this delay, it is possible the user did not select the most recent dicom before completing the registration process and therefore did not use the most recent navigational position information.Labelling review: "warnings, cautions and precautions.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." "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." ".Movement of the patient during the course of 3d radiographic image acquisition may result in inaccurate measurements.Efforts to immobilize the patient during data acquisition should be taken to restrict patient movement.If patient movement during data acquisition is observed or suspected, re-start the data acquisition process in order to ensure accurate image." ".Capturing the patient reference arrays for registration can happen before you drape or after you remove the drape from the patient reference arrays during 3d image acquisition for navigation.Make sure to gently drape over the patient reference arrays, ensuring the arrays are not bumped or moved in this process.Any movement of the arrays during this process could require a re-capture of the arrays, or even re-scan of the patient if the registration accuracy is not adequate.".

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 16552917
• Report Number: 2031966-2023-00047
• Device Sequence Number: 11486242
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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?: 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: 02/26/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RELINE MAS PEDICLE SCREW
• Patient Sex: Prefer Not To Disclose