MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number SEE H10

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

No product malfunction was alleged so no product were returned for evaluation.No radiographs were provided so the complaint could not be confirmed.No definitive root cause can be determined although review of the reported event identified a surgical error related to three pedicle screws being malplaced and repositioned during the fixation phase, as well the application of post fixation compression in addition to the extended retraction time as possible cause or contributors to the reported event.No additional investigation can be completed.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: spinal cord or peripheral nerves; loss of sensory and/or motor function and permanent pain and/or deformity." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma, bursitis, paralysis." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery." ".All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Method of use: please refer to the surgical technique for this device." ".Information: to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at.".No device returned.

Event Description

During an extreme lateral interbody fusion at l3/5 with posterior fixation procedure on (b)(6) 2023 the left l3, l4 and l5 pedicle screws were identified as malpositioned removed and reinserted in a different position.Compression was applied and the surgery was completed.Postoperative mep and showed that the left quad did not respond well.No additional injuries were reported.

Event Description

It was reported that the patient underwent an initial two (2) level extreme lateral interbody fusion with percutaneous posterior fixation from l3 to l5.During the procedure, the pedicle screws at left l3, left l4, and left l5 were placed and were subsequently removed and reinserted due to malposition.After the procedure was completed, it was noted that post-operative meps (motor evoked potentials) showed that the left quadricep did not respond well.The movement of raising the knee appeared weak when the patient awoke.The patient is being monitored.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: it is unknown what screw may have been associated with the reported event: model #16026535, udi (b)(4), lot #tz00912r; model #16027535, udi 887517556974, lot #jp26857; or model #16027535, udi (b)(4), lot #tz01816.H4: (b)(6) 2022, (b)(6) 2022, or (b)(6) 2022.The reported event was unable to be confirmed due to limited information received from the customer.There was no product malfunction alleged as a part of the reported event and no device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of manufacturing records was performed and no discrepancies relevant to the reported event were found.It is unknown if the muscle weakness upon waking was related to the repositioning of screws during implantation.A definitive root cause was unable to be determined with the information provided.Labeling review: "¿potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels, spinal cord or peripheral nerves.Loss of sensory and/or motor function." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury.Nerve damage due to surgical trauma.Paralysis." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16969764
• MDR Text Key: 315673229
• Report Number: 2031966-2023-00113
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELINE COMPRESSION INSTRUMENTATION; RELINE LOCK SCREWS; RELINE RODS; RELINE SCREWS
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female