MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE MODULUS ALIF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	1305225
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned to nuvasive for evaluation as they remain in-situ, no radiographs or images have been provided so the complaint could not be confirmed.Review of the reported event identified 9 month after the placement procedure the anterior lumbar interbody blade had backed out and the surgeon suspects the screw lock latch failed to engage.No images or device return was available so a definitive root cause could not be determined although physical damage to the blade and or blade lock, physical obstruction of the blade lock, or insufficient advancement of the blade into the lock mechanism could be the cause or contributors to the postoperative blade backout.Should more information be provided an additional investigation will be completed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.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 as with any major surgical procedures, there are risks involved in spinal/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)." "warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.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." ".If fewer than 3 bone screws are used, then the system is intended to be used with additional supplemental fixation (cleared by the fda) for use in the lumbar spine.When using anchoring blades, only insert the blades into the medial holes of the nuvasive modulus alif system interbody as per the surgical technique (doc #9514691).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." ".Based on fatigue testing results, when using the modulus alif system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.Additional care should be taken at the lower levels of the lumbar spine due to the obstruction of anatomical structures, such as the iliac crest and iliac vessels, surgical access for the subject device at these levels may not be feasible.Care should be taken to confirm that all components are ideally fixated prior to closure." "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." "pre-operative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.3.Care should be used in the handling and storage of the modulus alif implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the modulus alif implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the modulus alif implants if there is any evidence of damage.4.Refer to cleaning and sterilization instructions below for all non-sterile parts.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient."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 other complications.To help ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." "method of use please refer to the surgical technique for this device." "handling of the sterile implant before removing the implants from the package, make sure that the protective packaging is unopened and undamaged.If the packaging is damaged, the implants have to be considered as non-sterile and may not be used.Upon removal from the package, compare the descriptions on the label with the package contents (product number and size) note the sterile expiry date.Implants with elapsed sterile expiry dates have to be considered as non-sterile and may not be used.Take particular care that aseptic integrity is assured during removal of the implant from the inner packaging.Open the packages carefully.Take suitable measures to help ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used." 9400085-en j-2024-05.
Event or Problem Description
On (b)(6) 2023 a patient underwent an anterior lumbar interbody fusion (alif) at an unreported level.On (b)(6) 2024 a follow up took place due to an identified postoperative infection from another surgery unrelated to nuvasive devices and films identified an alif blade had backed out of the interbody, this patient had multiple surgeries and was very unhealthy.No revision surgery for anything related to the blade backing out has been planned.We believe it is as because the latch did not pop back out after the blade pushed it out and advanced into the pocket.

• Brand Name: NUVASIVE MODULUS ALIF SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 21903525
• Report Number: 2031966-2025-00075
• Device Sequence Number: 8713534
• Product Code: OVD
• UDI-Device Identifier: 00195377150639
• UDI-Public: 195377150639
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K230894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: 1305225
• 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: 08/14/2024
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown