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

Model Number	10000751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation and no photographs were provided so the complaint could not be confirmed.No associated torque handle information was provided.Although no definitive root cause could be determined, review of the reported event and similar events suggests excessive off angled force and or fatigue failure after repeated high torque use over time as the likely cause or contributors.The fractured tip per surgeon¿s prerogative was left in-situ and a literature review confirms the stainless-steel materials that were unretrieved in this event can be considered to exert very low toxicity potential and to pose negligible risk to the patient.No additional investigation can be completed.Manufacturing review: no lot code information was provided so the device age could not be determined, nor could a complete manufacturing review be completed.Labeling review: "residual risks to the patient associated with use of general surgical instruments are cleaning and sterilization failures, sterile barrier compromise, corrosion, and unretrieved instrument fragments which may cause or contribute to infections, fever, wound dehiscence, immunological response and immunological, systemic, or allergic reactions.In some instances, treatment of these events may require surgical intervention including revision surgery." "instrument malfunctions which potentially result in surgical delays (thereby causing additional exposure to anesthesia, blood loss, and infection), a change in surgical plan, failure to achieve optimal clinical result and/or, infrequently, cancellation of a procedure.Such malfunctions include instrument fracture, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration; instrument fracture may also result in injury to the patient." "residual risks to surgical staff associated with use of general surgical systems are.Instrument failures or malfunctions which prevent intended use, resulting in decreased operational efficiency and general inconvenience." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery." "pre-operative warnings the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures." "the instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury." "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "intra-operative warnings the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." "the physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." "method of use if there is any doubt or uncertainty concerning the proper use of instruments, please contact nuvasive.Customer service.Any available surgical techniques will be provided upon request.For optimal results, the same type of instruments used for implantation should be used for implant removal." "information to obtain a surgical technique manual or other applicable instructions for use or should any information.Regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com." 9004421-en w-2022-12.Literature review: review of biocompatibility of stainless steel for use in nuvasive, inc.Medical instruments final report (08/17/2016) has provided sufficient supporting documentation for the stainless-steel type 17-4, stainless steel type 455, stainless steel type 465, and stainless-steel type 316 used in the nuvasive, inc.Medical surgical instruments at locations of potential instrument failure to be considered biocompatible.The potential long-term exposure of lodged or embedded stainless steel material in the event of instrument failure was reviewed.The aforementioned materials were determined to possess a chromium oxide passivation layer which serves to create a material with negligible potential for leachable metallic elements and virtually no potential for material-induced toxicity.Therefore, in situations where the physician has determined that removal of the instrument fragment is not possible and the only safe option is leaving it embedded in the patient, these stainless-steel materials can be considered to exert very low toxicity potential and to pose negligible risk to the patient.See test report (b)(4) for more detail.
Event or Problem Description
During final tightening process, driver tip sheared off inside lock screw cap.Piece was not retrievable from patient, would require drilling out of the lock screw and would compromise the pedicle screw lock screw interface.Confirmed that setscrew was in line with the tulip head for final tightening.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: 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: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 21990506
• Report Number: 2031966-2025-00084
• Device Sequence Number: 17221282
• Product Code: NKB
• UDI-Device Identifier: 00887517513724
• UDI-Public: 887517513724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: 10000751
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown