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

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

Patient Problems Unspecified Infection (1930); Rash (2033)

Event Date 11/26/2022

Event Type  Injury  

Event Description

It was reported on a clinical study that a patient underwent a spinal procedure at l3/5 on (b)(6) 2022.On november 26, 2022 at a rehab facility the patient experienced a superficial wound infection - wound separated at dermis with drainage.Wound culture grew pseudomonas.Treatment was iv antibiotics (zosyn) and follow-up with infection disease specialist.Then 6 weeks later during a post-op visit it was reported there was a rash on the extremities & trunk; thought to be related to iv antibiotics for superficial wound infection.Treatment was referral to infectious disease specialist & changed antibiotics.No additional injuries reported.

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 material numbers or lot codes were provided so it is unknown if this was a sterile or non-sterile implant and no manufacturing review could be completed.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.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.3.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.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." "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 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." "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.Instruments with a ¿d¿ prefix part number (e.G.Dxxxxxxx) may be disassembled.Please refer to the additional disassembly instructions for these 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 # (b)(4))." "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 (b)(6).

• 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: 18489536
• MDR Text Key: 332601071
• Report Number: 2031966-2024-00011
• 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
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose