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

Device Problems Break (1069); Fracture (1260)

Patient Problem Pain (1994)

Event Date 03/29/2023

Event Type  Injury  

Event Description

On unknown day in (b)(6) 2021, a patient underwent a t10 to s2 posterior fixation procedure.On an unknown day in (b)(6) 2023, the patient heard a noise when getting up.On (b)(6) 2023 it was reported that the patient was experiencing back pain.After examination and it was found that the left rod had fractured around l3/4.No information has been received indicating whether medication was given for the he pain or if a revision procedure has been planned or performed.

Manufacturer Narrative

No device was returned as the implant remains in-situ; however, a provided radiograph was able to confirm the reported event as a rod fracture can be seen on the left rod between the l3 and l4 pedicle screws.Note: a review of the radiograph showed an extensive multi-rod fixation construct located just below the fracture site, indicating a potential history of loading challenges and rod fractures.No information on the patient's post-operative activity levels was provided.Based on the information obtained, the root cause of the reported event is unknown but may be the result of excessive loading.No additional investigation required.Labeling review: "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 component(s); loss of fixation; nonunion or delayed union." "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.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." not returned to manufacturer.

Event Description

It was reported that the patient underwent a posterior fixation procedure from t10 to s2.Subsequently, the patient reported hearing a noise upon standing approximately 18 months later.The patient reported pain and an examination identified fracture of the left rod at left l3/4.The patient underwent a revision procedure to correct the fractured rod approximately four (4) months later.No further patient impact was reported.No additional information was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The patient underwent a revision procedure.No product was returned to nuvasive for evaluation.

Event Description

N/a.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned to nuvasive for evaluation as the device remains implanted.A radiograph of the reported issue was provided and the reported rod fracture was confirmed.Review of the radiograph identified a dual rod construct from t10 to l3/4 and a multi-rod construct from l3/4 to s2/iliac.It is unknown if the entire construct was implanted during the initial procedure or added at a later date.The rod fracture could be seen just below the l3 pedicle screw and above the interface of the superior-most rod-to-rod connector.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.Details regarding the patient's activity level, surgical history, and/or preexisting conditions were not provided for review.The root cause of the reported issue was unable to be determined with the information provided; however, the location of the rod fracture indicates the transition in stiffness of the fixation construct at the junction between dual-rod and multi-rod fixation to be a contributing factor.Labeling review: ".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.Pain, discomfort or abnormal sensations due to the presence of the device." ".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." ".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: geoffrey gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16824011
• MDR Text Key: 314099645
• Report Number: 2031966-2023-00093
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223181
• 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,Followup,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• 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: 07/25/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose