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

Model Number 1881500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation because no fault was alleged on the device.No radiographs or test results were provided to confirm the reported event.It was reported that the device navigation was used to identify the pedicle screw placement location and trajectories; however, a freehand technique was used to cannulate the pedicles and place the pedicle screws.Therefore the pulse system did not contribute to the unfavorable placement of the right t10 and t11 pedicle screws.Additionally, although the t10 and t11 screws were reported to have been placed unfavorably, whether this was the cause of the patient's foot drop and loss of feeling could not be established.Based on the information obtained the root cause of the reported event is unknown but may be the result of unfavorable screw placement due to surgical technique.Additional patient information was requested but not received.Labelling review: "potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications include: tissue or nerve damage, including due to improper positioning and placement of implants or instruments; sensory or motor deficits.".Potential pulse system failures include the following, which can cause serious or critical patient injury, including many of the adverse events noted above: navigational failures/inaccuracies, or system failures preventing the use of navigated guidance; inaccurate planning, instrumentation recommendations, and/or spinal parameter measurements." "warnings, cautions, and precautions.All the instruments must be confirmed before using for navigation as not doing so can lead to navigation error." "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." device not returned to manufacturer.

Event Description

A case was performed on patient levels t10 to pelvis in which the surgeon used pulse navigation for pedicle targeting via the use of a pointer.After identifying the screw insertion location and trajectory via system navigation the surgeon then cannulated the pedicle with a freehand technique.A ball tip feeler was then used to feel for bone within the cannulated pedicle and the screws were placed.Following screw placement it was noted that the right t10 and t11 screws were in an unfavorable position.On a post operative examination the patient reported right leg feeling loss and foot drop.As of (b)(6) 2022, the patient has regained some feeling but foot drop still present.

• Brand Name: NUVASIVE PULSE SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 15905866
• MDR Text Key: 304709376
• Report Number: 2031966-2022-00274
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2022

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?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK BALL TIP PROBE.; UNK GEAR SHIFT PROBE.; UNK PEDICLE SCREWS.; UNK POINTER.
• Patient Outcome(s): Disability
• Patient Sex: Prefer Not To Disclose