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

Device Problem Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Pain (1994); Paresthesia (4421)

Event Date 11/05/2022

Event Type  Injury  

Event Description

It was reported in a clinical study that a patient underwent a procedure on (b)(6), 2022 and on (b)(6), 2023 there was a durotomy during re-operation.Treatment was duraseal placed over the defect and a lumbar drain was placed in the intralaminar space at l2-l3.A combination of surgi-flo & bipolar cautery was then used for hemostasis.The patient also reported right leg pain with paresthesias & weakness since surgery.Treatment was medication & physical therapy.No additional injuries reported.

Manufacturer Narrative

This complaint has been created from a clinical study review so no product returned for evaluation and no images were provided so the complaint cannot be confirmed.Review of the provided information identified a surgical error took place causing an incidental durotomy unrelated to nuvasive product functionality and likely of inadvertent instrument contact.No additional information provided and no additional investigation can be completed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury.Pain, discomfort or abnormal sensations due to the presence of the device dural leak"."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.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 the these levels may not be feasible.Care should be taken to ensure that all components are ideally fixated prior to closure." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at +1-800-475-9131.You may also email: info@nuvasive.Com." 9402506-en h-2022-06 h3 other text : device in-situ.

• Brand Name: NUVASIVE MODULUS XLIF 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: 18489538
• MDR Text Key: 332602694
• Report Number: 2031966-2024-00012
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201692
• 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
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 12/21/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VARIABLE ACCESS INSTRUMENTATION
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose