MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE MODULUS XLIF INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1181855P2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent a lateral interbody fusion procedure from l2 to l4.The surgery was completed with out issue or complication to the patient.The patient had a subsequent follow up and no issue was found with the patient or construct.On (b)(6) 2023 the patient had another follow up appointment where it was discovered the implanted cage at the l3/l4 level had fractured in half.The patient claims to have experienced no falls or other accidents and is currently experiencing no adverse pain or consequences as a result of the fractured implant.The cage currently remains in situ with no current plans for revision.The patient is under observation and will continue to be monitored.
Additional Manufacturer Narrative
The device was not returned to nuvasive for evaluation as it was left in-situ as completed fusion was reported, radiographs provided confirm the complaint.The patients bone quality is unknown.The patient reportedly had no falls but postoperative physical activity is unknown.The patient is reportedly asymptomatic.Anterior radiographic review noted cropped poor quality images were tough to read and could not confirm the size or placement of the total construct.Observations include no device failure with posterior fixation devices though unilateral fixation inferior to the caudle fractured interbody was noted, as well the cage appears to be in two pieces with the left half protruding past the vertebral margin approx 5mm but appears to have fused.Additionally excessive tilt of the superior interbody was observed suggesting possible poor bone quality and oblique subsidence although unconfirmed due to image restrictions.Due to image obscurity the only noted observation on the lateral radiograph was the cranial interbody implant is at the far anterior disc space margin.A definitive root cause could not be determined however, radiographic image review suggests the patients bone quality, implant positioning, unilateral fixation inferior to the interbody, end plate preparation and or excessive postoperative physical activity as likely cause or contributors to the identified postoperative fracture.No additional investigation can be completed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "contraindications: contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice; patients with inadequate bone stock or quality; patients with physical or medical conditions that would prohibit beneficial surgical outcome; prior fusion at the level(s) to be treated." "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, decrease in bone density due to stress shielding, degenerative changes or instability of segments adjacent to fused vertebral levels, malalignment of anatomical structures (i.E.Loss of normal spinal contours or change in height)." "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." "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 interbody 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." "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: only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used in the handling and storage of the modulus 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 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 implants if there is any evidence of damage.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 ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." device remain in situ.

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16482464
• Report Number: 2031966-2023-00038
• Device Sequence Number: 12632971
• Product Code: MAX
• UDI-Device Identifier: 00887517726063
• UDI-Public: 887517726063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/03/2023

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: 1181855P2
• 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: 02/07/2023
• Initial Report FDA Received Date: 03/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POSTERIOR FIXATION
• Patient Age: 77 YR
• Patient Sex: Male