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

Model Number	13116545
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	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation and no radiographs were provided to confirm the complaint.Patient's post-operative physical activity and bone quality are unknown.No root cause could be determined as review of the information provided identified excessive loading as a result of cage migration as a possible cause of screw loosening though the noted parkinson's disease and the patient's unknown post-operative physical activity may be an additional cause or contributor.No additional investigation can be completed.Labeling review: ".Contraindications: contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice.Patients with inadequate bone stock or quality.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".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 components, loss of fixation." ".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.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.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: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".
Event or Problem Description
On (b)(6) 2021 a patient underwent a spinal procedure at l2/4.On an unknown date it was discovered that the interbody was displaced laterally (200061169) due to the loosening of a spinal screw at l2 or l4.On (b)(6) 2022 a revision surgery was conducted where the l2 and l4 screws were replaced and competitor's interbodies were inserted at l4/5/s.No patient injury reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13455713
• Report Number: 2031966-2022-00028
• Device Sequence Number: 4675361
• Product Code: NKB
• UDI-Device Identifier: 00887517582508
• UDI-Public: 887517582508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/04/2022

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: 13116545
• Device Lot Number: N297796
• 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: 01/19/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7180027006
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG