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	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an extreme lateral interbody fusion with posterior fixation using pulse system navigation.During pedicle screw placement for the posterior portion of the case the surgeon placed a screw that was accurate, then a second screw was placed, which the surgeon felt was inaccurate.The surgeon stimulated the placed screw, which displayed red, indicating the screw was close to a nerve, confirming it was not placed in the intended location.The malplaced screw was removed.The tracking reference array was re-secured.System accuracy was re-established.The case was continued with the remaining screws placed accurately and no additional issues.
Additional Manufacturer Narrative
No device was returned to the manufacturer; however, an on-site representative was able to evaluate the system following the case.Testing was able confirm the system navigation was accurate.Additionally, as re-securing the reference array and performing an additional re-registration scan was able to re-establish system accuracy during the case, it was determined that the system was performing as intended.Based on the information obtained, the root cause of the reported event is unknown, but may have been the result of intraoperative shifting of a reference array.Labeling 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." ".The pulse system is to be used only as an adjunct to medical judgment and appropriate surgical practices." "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." ".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 boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18234705
• Report Number: 2031966-2023-00278
• Device Sequence Number: 12552778
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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?: 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: 11/01/2023
• Initial Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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