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

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient underwent a posterior fixation procedure from t10 to l3 and the surgery was completed with issue.On a unknown date it was discovered that the pedicle screws at l2 and l3 were found to be in malposition.No additional details could be provided regarding the malpositioning.The patient was reported to be experiencing no adverse symptoms.On (b)(6) 2024 a revision surgery where the pedicle screws at l2 and l3 were explanted and reinserted.The patient is reported to be recovering.

Manufacturer Narrative

There was no product returned for evaluation as no product fault was alleged, the implant was reutilized during the revision procedure and currently remains in situ.No radiographs or operative notes were provided for review and the reported event could not be confirmed.No material or lot number could be provided so a review of the manufacturing history could not be performed.Based on the information provided, the root cause is considered to be an inadvertent use error and the result of screw malplacement during the implantation procedure.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.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." "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." "method of use - please refer to the surgical technique for this device.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 (b)(6).You may also email: (b)(6)." h3 other text : device remains in situ.

Event Description

It was reported that the patient underwent an initial five (5) level posterior fixation procedure from t10 to l3.Subsequently, on an unknown date, the pedicle screws at l2 and l3 were found to be in an improper position.No additional details could be provided regarding the malposition of the screws or if the issue occurred unilaterally or to both screws.There were no reports of pain by the patient.Subsequently, approximately three (3) months post-op, the patient underwent a revision procedure to explant and reinsert the pedicle screws at l2 and l3.Additionally, posterior lumber interbody fusion (plif) was performed at l3/l4 and l4/l5, and the construct was extended to s2ai.No radiographs were available for review.The patient is reported to be recovering.No further patient impact was reported.No additional information is available.Report 1 of 2.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.It is unknown if the screws were placed in the appropriate position during the initial procedure.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.Information regarding the patient's bone quality, post-operative activity levels, or if they experienced any trauma was not provided.The root cause of the issue was unable to be determined with the information provided.Labeling review: ".Contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality." ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); loss of fixation; nonunion or delayed union." ".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.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." ".Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Pre-operative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." 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, 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: 18734147
• MDR Text Key: 336764607
• Report Number: 2031966-2024-00058
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female