MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	12355120P
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs were provided for review.Three post-operative radiographs were provided for review and were able to confirm the reported event as inferior movement of the right-side rod could be seen between the image take on (b)(6) 2024 and the images taken on (b)(6) 2025.Information regarding the torque handle used was not provided.Information on the patient's activity or whether a fall was sustained was not provided.Based on the information obtained a root cause of the reported event was unable to be determined, but may have been the result of insufficient torque on lock screws during final tightening, insufficient rod reduction and or normalization, or post-operative excessive physical activity.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: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip." ".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." ".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.".
Event or Problem Description
On (b)(6) 2024 a patient underwent a posterior vertebral replacement procedure with posterior fixation from l2 to l4.The surgery was completed without issue to the patient.On (b)(6) 2025 during a routine follow up the patient reported experiencing pain.Radiographs were taken and it was discovered that the right-side rod had dislocated through inferior translation through the construct with additional impact to other spinal implants.To date, no revision surgery has been planned.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 21574687
• Report Number: 2031966-2025-00037
• Device Sequence Number: 20889278
• Product Code: PML
• UDI-Device Identifier: 00887517036216
• UDI-Public: 887517036216
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K180498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 12355120P
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 80 KG