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

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

No device was returned but two radiographs were provided confirmed the alleged complaint.The patients post op activity levels or whether they experienced a fall or other accident could not be confirmed.Review of the reported event identified the patient was asymptomatic and had fully fused after having the implants in-situ for two years 10 months.The root cause of the fractured device is considered end of life and is the result of loading changes related to completed fusion.No additional investigation required.Label review: "contraindications; contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." "potential adverse events and complications; potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "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."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." "the expected life cycle of implants is determined through astm f1717 testing (astm f1717 standard test methods for spinal implant constructs in a vertebrectomy model).5 million cycle endurance limit in astm f1717 represents 2.5 years of in vivo usage per the rationale presented here: "the purpose of spinal fusion implants is to provide short term stability until arthrodesis takes place.Following fusion, the device is expected to be unloaded due to load-sharing with the newly formed bone mass.Spinal fusion should occur within 12 months of surgery.¿ according to hedman¸ et al.(1991), the average person makes approximately 2 million strides per year (1 million gait cycles).Testing to 5 million cycles is equivalent to a lifetime of approximately 2.5 years of activity, providing a safety factor of 2.5." h3 other text : no device returned.

Event Description

On (b)(6) 2020 a patient underwent a posterior fixation procedure from l1 to l5 to address a l3 vertebral fracture.The surgery was completed with no patient issues.On (b)(6) 2023 images were taken for a potential removal surgery as the patient had successfully fused.Images reviewed for the procedure confirmed the left rod had fractured between the l1 and l2 and the left l2 pedicle screw had fractured.The patient was reported to be asymptomatic.The removal procedure occurred as intended, all implants were removed from the patient.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17567293
• MDR Text Key: 321378056
• Report Number: 2031966-2023-00173
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132014
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/18/2023
• 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
• Patient Sequence Number: 1
• Treatment: UNKNOW RELINE ROD; UNKNOW RELINE SCREW
• Patient Age: 42 YR
• Patient Sex: Male