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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Paralysis (1997)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a spinal procedure from t10 to l5 using reline products.Approximately three months later, the patient experienced a vertebral body fracture at t10 and paralysis, which reportedly occurred due to adjacent segment disease in addition to fusion not being achieved.Subsequently, a revision surgery was performed where the pedicle screws at t10 were removed and the construct was extended to t7 with a dual-rod fixation.No additional issues were reported and no additional information has been made available.

Manufacturer Narrative

No product was returned as no malfunction was alleged and no images were provided to confirm the reported event.The patient's bone quality, medical history, and post-operative physical activity are unknown and it is unknown if the patient suffered a fall.Due to lack of information, a definitive cause cannot be determined; however, review of the reported information indicates the patient's continued pathology is a cause or contributor.Additionally, it was reported that fusion had not been achieved, which may indicate patient anatomical/medical conditions and/or lifestyle (e.G.Physical activity) may have been factors.Labeling review: ".Contraindications: contraindications include, but are not limited to: patients with physical or medical conditions that would prohibit beneficial surgical outcome.Patients who are unwilling to restrict activities or follow medical advice." ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Fracture of the vertebra, paralysis." ".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.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: patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16010540
• MDR Text Key: 305776578
• Report Number: 2031966-2022-00288
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 65 KG