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

Model Number 1225250

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been created from a clinical study review so no product returned for evaluation and no lab reports or images were provided so the complaint cannot be confirmed.A definitive root cause cannot be determined though post operative infection is a known complication of spinal surgery.Nuvasive non-sterile implants and instrumentation are cleaned and processed by the end user and sterilization records were not provided.No additional investigation can be completed.Labeling review: ".Contraindications: contraindications include, but are not limited to: infection, local to the operative site.Signs of local inflammation." ".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 include: early or late infection.Potential risks identified with the use of this system, which may require additional surgery, include: infection." ".Warnings, cautions and precautions: care should be taken to ensure that all components are ideally fixated prior to closure." ".Pre-operative warnings: 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 devices and injury to the patient." ".Cleaning and decontamination: all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions doc 9400896 before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments." ".Sterilization: all non-sterile instruments are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasive¿s validated parameters.In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the nuvasive cleaning and sterilization instructions doc 9400896." device in-situ.

Event Description

It was reported on a clinical study that on (b)(6) 2022 a patient underwent an extreme lateral interbody fusion at l4/5.On (b)(6) 2022 the patient had an er visit during which she had wound vac applied for infected lower posterior back wound.On (b)(6) 2022 the patient supposedly underwent incision and drainage for the wound dehiscence.

• Brand Name: NUVASIVE MODULUS XLIF INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15784439
• MDR Text Key: 303572171
• Report Number: 2031966-2022-00251
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517726919
• UDI-Public: 887517726919
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1225250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female