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

Model Number	13115540
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation but multiple photos of the explanted device as well as three films were provided confirming the alleged complaint.The patient bone quality could not be confirmed.The patients post op activity levels could not be confirmed, it could not be confirmed if they experienced any falls or other accidents.During the revision procedure it was confirmed fusion had not taken place 414 days after patient implant.Evaluation of the radiographic images provided identified the screw fractured at approximately 10-15mm from the shank head with what appears to be high cycle flexural load fracture and likely the result of excessive loading due to the noted pseudarthrosis.Additionally, both screws at l4 were observed to have been initially implanted at an extreme angulation.The root cause could not be determined but review of the information provided suggests implant selection and placement, bone quality, excessive post operative physical activity and or patient related factors (pseudarthrosis).No additional investigation required.A review of the manufacturing history found no material nonconformance, no manufacturing error, nor discrepancies with respect to material type, treatments or dimension that may have caused or contributed to this event.Parts met acceptance criteria upon release.No additional investigation can be completed at this time.Label review: "potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries"."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 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." "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.".
Event or Problem Description
On (b)(6) 2023 a patient underwent a posterior fixation procedure from l4-l5.The procedure was completed without issue.On a unknown date in october 2023 the patient was experiencing an internal cracking sound so she went in to the doctor where it was observed a screw had fractured on the right side of the construct at the l4 level.The patient was asymptomatic so nothing was done at that time and the patient continued to be observed.On a unknown later date the patient began to complain of pain.As a result on (b)(6) 2024 a revision procedure occurred where the entire construct was removed and new pedicle screws were implanted.The revision was completed with no adverse patient consequences.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19657829
• Report Number: 2031966-2024-00167
• Device Sequence Number: 17871105
• Product Code: NKB
• UDI-Device Identifier: 00887517582218
• UDI-Public: 887517582218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/02/2024

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: 13115540
• Device Lot Number: N333895
• 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: 06/05/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female