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	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An on-site representative was able to provide additional information on the reported event and confirmed that after replacing the marker spheres on the associated array, the navigated drill was accurate and was used for the rest of the case with no additional navigation inaccuracies.It was also reported that the spheres on the associated array were not replaced following draping.The product reference manual recommends the user change spheres following draping before 3d image acquisition to reduce the risk of navigational inaccuracies due to potentially damaged spheres.Based on the information obtained, the most probable root cause of the navigational inaccuracy was scuffing on the spheres due to the arrays spheres not being replaced after being draped previously in the procedure.The instruction for use and product reference manual recommend replacing spheres due to the potential for navigational inaccuracies to arise.Labelling review: "caution: it is recommended that the user changes spheres before the first 3d acquisition if pulse 3d navigation is being used to account for potentially damaged spheres.This change should be done after any drape is removed from the cios spin, and immediately before the cios spin is used for the 3d image acquisition.All of the spheres should be checked for secure fixation before the 3d spin is conducted.Failing to change the spheres has the risk of navigation inaccuracy due to potentially damaged spheres."."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.".".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." h3: not returned to manufacturer.
Event or Problem Description
It was reported that a non-nuvasive device, indicated for use with the system, was used to drill a pilot hole in the pedicle on an unknown spinal level using navigation.A pedicle screw was then inserted into the hole but a subsequent confirmation scan found the screw to be a few millimeters deeper than intended and that the accuracy of the navigated drill appeared to be a few millimeters off in depth.The surgeon reported the screw position was considered acceptable and no screw replacement was necessary.

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 17004428
• Report Number: 2031966-2023-00119
• Device Sequence Number: 17713642
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/25/2023

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: 05/01/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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: MEDTRONIC STEALTH-MIDAS MR8 DRILL
• Patient Sex: Prefer Not To Disclose