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

Catalog Number N/A

Device Problem Fracture (1260)

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

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial extreme lateral interbody fusion procedure at unknown level(s).Seven (7) days later, the patient underwent a secondary procedure to add posterior fixation from t8 to sai.Approximately four (4) years later, during a routine follow-up appointment, it was discovered that the fixation rods on both sides of the construct and one rod to rod connector were fractured near the l3 vertebral body.The patient was noted to be asymptomatic.Subsequently, the patient underwent a revision procedure to replace the fractured implants and reinforce the fixation construct with bilateral dual rods.No further patient impact was reported.No additional information is available.Report 3 of 3.

Manufacturer Narrative

No product was returned to nuvasive for evaluation; a radiograph of the reported issue was provided and the complaint was confirmed.Review of the radiograph identified the left and right rods were both fractured near the l3/l4 disc space, above the l4 pedicle screws.Additionally, the rod to rod connector attached to the left rod, above the left l3 bone screw, was fractured in the center of the connector attachment features.Coronal plane curvature of the patient's spine was present from l2 to l5 and was most prevalent at the l3 vertebrae, just cranial of the fracture locations.No operative notes or radiograph images from the initial procedure were provided for review of usage/technique.It was noted that the patient had degenerative scoliosis.Information on the patient's post operative activity level and if the patient experience any fall or other trauma was unknown.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided; however, excessive loading caused by continuation of pathology likely contributed to the implant fracture.Labeling review: ".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)." ".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.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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18723147
• MDR Text Key: 335701117
• Report Number: 2031966-2024-00056
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• 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): Hospitalization
• Patient Sex: Female