MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE PULSE III MULTIMODALITY SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	5050401
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	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received and no radiographs could be provided; however, an on-site representative was able to confirm the reported event.As reported by the operating physician and the company representative, the navigation inaccuracy that was experienced was likely caused by two factors: 1) bumping of the patient array during the procedure, 2) potentially having non-ideal fixation of the patient array on spinous process as it was positioned and adjusted prior to the starting navigation.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 patient reference array needs to be fully secured on the patient reference for tracking.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.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.".
Event or Problem Description
A patient underwent a c1 to c5 posterior cervical fusion case for which the two screws located at c1 and two screws located at c2 were placed using the pulse iii system navigation.After screw placement, it was identified that the two screws at c1 appeared 3-4 mm off of the intended location in the sagittal plane.During post-operative evaluation on a 3d radiograph it was determined that the screws did not require repositioning.

• Brand Name: NUVASIVE PULSE III MULTIMODALITY 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: 14002297
• Report Number: 2031966-2022-00071
• Device Sequence Number: 17241785
• Product Code: OLO
• UDI-Device Identifier: 00195377051004
• UDI-Public: 195377051004
• 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): 04/04/2022

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: 5050401
• 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: 03/07/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PULSE III SYSTEM
• Patient Age: 62 YR
• Patient Sex: Male