MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vertebral Fracture (4520)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported in a clinical study that a patient underwent a extreme lateral interbody fusion at l4/5 on (b)(6) 2022.On (b)(6) 2022 the patient stated her pre-op pain is ongoing with sharp pain in her left buttock that radiates down the left foot.Upon review of scans, l5 level has a new compression fracture with about 50% height loss.Treatment was a l5 kyphoplasty with l4 laminectomy on december 12, 2022.No additional injuries reported.

Manufacturer Narrative

This was reported from a clinical study therefore no product was returne and no images were provided therefore the complaint cannot be confirmed.Patient's bone quality is unknown.It is unknown if the patient suffered a fall.Patient's post-operative physical activity is unknown.Though a definitive root cause cannot be determined review of the complaint report and other similar reports suggests bone quality, patient physical activity, and implant selection and or placement as possible cause or contributors.No additional investigation can be completed.Labeling review: "contraindications: contraindications include, but are not limited to: patients with inadequate bone stock or quality.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 orthopedic surgery.Decrease in bone density due to stress shielding." "warnings, cautions and precautions: 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.Based on fatigue testing results, when using the cohere thoracolumbar 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.Care should be taken to ensure 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: 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 during surgical procedures to prevent damage to the device(s) and injury to the patient." "post-operative warnings: 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." 9402772-en k-2022-06 h3 other text : device in-situ.

Event Description

N/a.

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18507564
• MDR Text Key: 332887200
• Report Number: 2031966-2024-00021
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/12/2024
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose