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	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An on-site representative was able to confirm the reported event.Pre-case navigational accuracy checks passed following recalibration.After the case, the imaging system and the pulse system were tested together and found to still be accurate.Two (2) concomitant devices, the drill guide and patient reference array, used during the case were also sent back to the manufacturer for evaluation.Testing found both of these devices to meet relevant specifications and to be functioning as intended.Based on the information obtained, the root cause of the reported event cannot be determined.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."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.
Event or Problem Description
During a case, following instrument registration and an accuracy check using anatomical landmarks using a pointer, k-wires were placed in the patient.A 2d radiograph radiograph was then taken, at which point the surgeon noted that the k-wires that were placed using surgical navigation looked too low relative to the intended location.An additional array registration was conducted to troubleshoot the inaccuracy; however, the system's suggested trajectories were still inaccurate.An alternate imaging system was brought in to complete the case.

• 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: 15579963
• Report Number: 2031966-2022-00200
• Device Sequence Number: 6461230
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/10/2022

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?: 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: 09/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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: PULSE DRILL GUIDEPN 5050267; PULSE SINGLE PATIENT REF ARRAYPN 5050401
• Patient Sex: Prefer Not To Disclose