MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE MODULUS ALIF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	1181050P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was identified during a review of the pmcf lumbar interbody study, the report identified that on (b)(6) 2023 a patient underwent a one level extreme lateral interbody fusion procedure at l3/4 with posterior fixation l3 to l4.On (b)(6) 2023 the patient underwent an anterior lumbar interbody fusion at l5-s1 as well as a transforaminal lumbar interbody fusion at l4/5 with the posterior fixation extended to l3 to s1.On (b)(6) 2023 the patient reported drainage from back incision.On (b)(6) 2023 the patient underwent a post-operative wound infection irrigation and debridement procedure, and received a picc line placed for iv antibiotics and eventually discharged on (b)(6) 2023 and considered resolved.
Additional Manufacturer Narrative
No product was returned for evaluation as no malfunction was alleged and product is still in-situ.No radiographs or lab reports provided so the complaint could not be confirmed.Review of the study report identified the patient presented with a postoperative wound infection requiring surgical and medical intervention.The root cause of the infection is unknown, but is a well known complication of spinal procedures and suggests possible environmental contamination though the type of infection was not provided.Nuvasive non-sterile devices are cleaned and sterilized by the user facility and sterilization records were not provided.No lot numbers were provided so a manufacturing review of the sterility of sterile implants involved could not confirmed with the vendor.No additional investigation can be completed.Labeling review: ".Contraindications: contraindications include but are not limited to: 1.Infection, local to the operative site.2.Signs of local inflammation." ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection;." ".Preoperative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.4.All non-sterile parts should be cleaned and sterilized before use 9500890 f." ".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 # (b)(4)) 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 nuvasive representative 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.".

• Brand Name: NUVASIVE MODULUS ALIF SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 20783851
• Report Number: 2031966-2024-00319
• Device Sequence Number: 5006280
• Product Code: OVD
• UDI-Device Identifier: 00887517020192
• UDI-Public: 887517020192
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K210271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1181050P2
• 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: 11/26/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5905936P2 INTERBODY; UNKNOWN RELINE FIXATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female