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

Model Number	1881500
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)
Health Effect - Clinical Codes	Vertebral Fracture (4520); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 an open posterior spinal fusion was performed on t10 to s1 with the assistance of navigation using the nuvasive pulse iii system.During the procedure, following placement of eight pedicle screws, the surgeon confirmed the screw placement using fluoroscopy and observed seven misplaced screws that had laterally breached.The surgeon removed and replaced the seven screws into their intended positions using fluoroscopy.No patient impact was reported.
Additional Manufacturer Narrative
The investigation is currently in process.Once the investigation has been completed, a supplemental report will be submitted.Device not returned.
Event or Problem Description
On (b)(6) 2021 an open posterior spinal fusion was performed on t10 to s1 with the assistance of navigation using the nuvasive pulse iii system.During the procedure, following placement of eight pedicle screws, the surgeon confirmed the screw placement using fluoroscopy and observed seven misplaced screws that had laterally breached.The surgeon removed and replaced the seven screws into their intended positions using fluoroscopy and the patient is reportedly doing well.
Additional Manufacturer Narrative
The device was not returned to nuvasive as it was inspected on site at the user facility, no device failure was identified but radiographs and on-site nuvasive staff confirm the event.Calibration and testing of the cios array and system could not recreate the inaccuracy and no malfunction was identified.Staff noted during the procedure the surgeon inadvertently moved the patient array and elected to move forward without recalibration and is suspected as the root cause.Surgeon education took place and monitoring will continue.".Warnings: 1.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.3.If system navigation seems inaccurate and re-registration steps to restore accuracy are not successful, abort use of the system.4.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.5.If data acquisition seems inaccurate, software application does not initiate or malfunctions during use, and recommended steps to restore the system are not successful abort use of the system.6.The pulse navigation system has been successfully tested against the requirements of iec 60601-1-2.However, radio frequency (rf) interference could hamper its operation or the operation of other nearby electrical devices.If you suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with a rf barrier, or discontinue use of the system.7.Movement of the patient during 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 to ensure accurate image.8.Scans from only calibrated intraoperative 3d imaging systems must be used for pulse navigation.Use of scans from uncalibrated imaging systems may lead to navigation error.37.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." ".Precautions: 14.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." updated information provided in sections: b1, b2, b4, b5, d9, g6, h1, h2, h3, h6, h10.

• Brand Name: NUVASIVE PULSE III MULTIMODALITY 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: 12897561
• Report Number: 2031966-2021-00171
• Device Sequence Number: 3900460
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1881500
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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 CAMERA, PRODUCT NUMBER 5000504
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose