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

Model Number	13550000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 a patient underwent a transforaminal interbody lumbar fusion from l3-l4 with posterior fixation being placed from l2-l5.On (b)(6) 2024 a revision surgery occurred due to loosening of lockscrew at the right l2 level and malpositioning of the right l5 pedicle screw.During the procedure it was also discovered the right l3 lock screw was loose.The left l2 and left l5 pedicle screws were replaced and the loosened lock screws were reinserted and retightened.
Additional Manufacturer Narrative
One lock screw was returned but no radiographs could be provided to confirm he alleged event.It is unknown whether hand tightening or a limiting torque handle was implemented during the index procedure.The patient post op activity levels and whether they experienced a fall or other accident is unknown.Examination of the returned lock screw identified markings consistent with contact with a unnormalized rod and cross threading.Review of the reported event identified the surgeon malplaced the l5 screw requiring revision.The root cause of the event is considered an inadvertent error as the malplaced screw led to rod placement difficulties, cross threading and the subsequent loosening of the lock screw.A review of the manufacturing history found no material nonconformance, no manufacturing error, nor discrepancies with respect to material type, treatments or dimension that may have caused or contributed to this event.Parts met acceptance criteria upon release.No additional investigation required.Label 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.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 - 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." "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." "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 (b)(6).You may also email: (b)(6).

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: 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: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 20182277
• Report Number: 2031966-2024-00199
• Device Sequence Number: 8298016
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• 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 Implanted Year: 2024
• 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): 08/19/2024

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: 13550000
• Device Lot Number: N373815
• 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: 07/22/2024
• Initial Report FDA Received Date: 09/10/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG