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

Model Number	12355300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent posterior lumbar interbody fusion procedure on unknown levels of the spine and the surgery was completed without issue.On a unknown date near the end of (b)(6) the patient was bending over and felt a pop.On (b)(6) the patient followed up with the surgeon and it was discovered via radiograph that a implanted rod had fractured.A revision occurred on (b)(6) 2021 where the fractured rod was replaced.During the revision the doctor noted pseudo arthrosis at l4-5, l5-s1.The patient is doing well post revision.
Additional Manufacturer Narrative
No product was returned and the radiographs provided were illegible and the complaint could not be confirmed.The patient was reportedly followed post op activity restrictions and did not experienced a fall or other accident.Review of the provided information identified pseudo arthrosis.No root cause can be determined however, delayed fusion and excessive loading are likely the cause or contributing factors.Label review ".Potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative nd 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." ".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.".
Event or Problem Description
On (b)(6), 2021 the patient experienced an l4 burst fracture requiring a transforaminal lumbar interbody fusion at l4-5 and l5-s1 and existing construct extension at l4-illium.On a unknown date near the end of (b)(6) the patient was bending over and felt a pop.On (b)(6), 2021 the patient followed up with the surgeon and it was discovered via radiograph that a implanted rod had fractured.On (b)(6), 2021 a revision for an identified rod fracture took place at l5, the rod was replaced.
Additional Manufacturer Narrative
The rod was not returned by the user facility and radiographs provided were unable to be read so the complaint was not confirmed.Interview with surgeon rep identified the patient and did not follow post-operative restrictions, has a history of spinal procedures and was very physically active.Surgeon noted pseudarthrosis at l4-s1.No bone quality report provided but noted as questionable.The root cause of the issue is considered patient related factors as as the long period of non-fusion, combined with suggested poor bone quality and excessive physical activity are all considered contributing factors.Labeling review: ".Contraindications: contraindications include, but are not limited to: 4.Patients who are unwilling to restrict activities or follow medical advice.5.Patients with inadequate bone stock or quality.6.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).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.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.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." ".Compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".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.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12747778
• Report Number: 2031966-2021-00152
• Device Sequence Number: 19995477
• Product Code: NKB
• UDI-Device Identifier: 00887517506764
• UDI-Public: 887517506764
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 12355300
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Prefer Not To Disclose