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

Model Number	16087545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned for evaluation; however, a photograph of the explanted devices was provided for review.Additionally, three radiographs were provided.Based on the photographs provided, the event was able to be confirmed as a fractured pedicle screw shank and fractured rod were seen in the images.Information on the patient's post-operative activity level or whether any trauma, such as a fall, had been sustained by the patient was not provided.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.Based on the information obtained, the root cause of the fractured screw could not be determined conclusively; however, per the initial reporter, the patient's index fixation procedure for a l3 vertebral body fracture was fixated at l1 to l2 and l4 to l5, which likely caused an excessive load around the l3 area, leading to the fractures seen.Labeling review: "potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.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.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." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.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.".
Event or Problem Description
On an unknown date a patient underwent a posterior spinal fixation procedure from l1 to l5.On an unknown date, it was found that one of the pedicle screws at the l2 location and the associated fixation rod had fractured.A revision procedure was conducted on (b)(6) 2024 for which the fractured screw head and rod were removed and refixation was conducted.No additional information was obtained.(report 1 of 2).

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 20434440
• Report Number: 2031966-2024-00263
• Device Sequence Number: 18243250
• Product Code: NKB
• UDI-Device Identifier: 00887517560056
• UDI-Public: 887517560056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 10/11/2024

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: 16087545
• Device Lot Number: AS7583
• 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: 09/03/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2018
• 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 Sex: Unknown