MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE COROENT TI-C SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 6130823P2

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

Patient Problem Unspecified Infection (1930)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation as they are still in-situ, no radiographs or lab reports provided so we are unable to confirm the reported infection.The type of infection was not reported, and medical intervention included unknown antibiotics.No revision surgery required and patient is reportedly improving.Post-operative infection is a known complication of surgical procedures that can be the result of environmental contamination, incomplete sterilization or patient related factors.Nuvasive instrumentation is consigned to the user facility and is cleaned and sterilized by the user facility, but sterilization records were not provided for review.Sterility of sterile implants involved in the case was confirmed by the vendor and specifications were met records are available to confirm.The investigation noted between the three reported infection cases that six different lot numbers were involved.Sterilization of implants took place at two different manufacturers and two different facilities.Additionally the involved interbody lots were manufactured and sterilized over a six-year period (2018, 2019, 2022, and 2023).All three infections took place at the same hospital with the same surgeon and no set information was provided.A definitive root cause could not be determined though review of all information suggests this may have been the result of environmental contamination.No additional investigation can be completed.Manufacturing review: review of the device history records notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "contraindications: contraindications include, but are not limited to: 1.Infection, local to the operative site."."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 infection."."pre-operative warnings: for sterile implants: assure highly aseptic surgical conditions and use aseptic technique when removing the modulus alif 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 alif implants if there is any evidence of damage."."packaging: all implants and instruments provided sterile are intended for single use only.Do not use if package is opened or damaged." "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 non-sterile and may not be used.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 the 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 nuvasive surgical instruments.Instruments with a d prefix part number 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 #9400896.".

Event Description

In three separate patients with interbody's placed, only the vertebral endplates where the cages contact appeared to be infected.The surgical incisions and pedicle screw sites were clear.All three patients have not undergone revision surgery currently and are improving with antibiotics.Complaint 1 of 3.

• Brand Name: NUVASIVE COROENT TI-C 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: geoffery gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18484244
• MDR Text Key: 332558072
• Report Number: 2031966-2024-00009
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517723017
• UDI-Public: 887517723017
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• 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
• Device Model Number: 6130823P2
• Device Lot Number: N313241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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: 6130923P2 LOT ML3052; 6130923P2 LOT N325823; 6130923P2 LOT N335050; 6130923P2 LOT N363543
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose