MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 02/15/2024

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient underwent a posterior fixation procedure from c7 to t9.The surgery was completed without any issues or adverse consequences to the patient.On a unknown date in (b)(6) 2024 it was discovered the surgical site had developed an infection.During post operative follow up it was also discovered the lock screw at left c7 and left t1 were dislodged.On (b)(6) 2024 a revision surgery occurred where the dislodged screws were explanted and replaced and the incision site was cleansed.The revision was completed with no further issue.It is unknown whether antibiotics were administered or not and no information could be provided regarding the type of infection, any potential consequences of it or its origins.This was the only infection that has been reported from this facility.

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received from the customer.However, there was no allegation received that nuvasive product caused or contributed to the reported infection and therefore no device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of device manufacturing records for the potential products involved was performed and no discrepancies related to the reported event were found.A definitive root cause was unable to be determined with the information provided.Surgical sets are sterilized at the user facility and no sterilizations records could be provided.Label review: "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." "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 reline cervical 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 reline cervical implants if there is any evidence of damage.4.Refer to cleaning and sterilization instructions below for all non-sterile parts." "packaging - packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.The instruments and implants of the system may be supplied as either sterile or non-sterile.All implants provided non-sterile are single use and should be sterilized per instructions provided below.Instruments provided non-sterile can be single-use or reusable.Discard single-use instruments after use.Reusable instruments should be reprocessed using instructions provided below.All implants and instruments provided sterile are intended for single use only.Do not use if package is opened or damaged.This product should not be re-sterilized.Discard single-use instruments after use." "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 # (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 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 and implants 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).".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18866377
• MDR Text Key: 337225330
• Report Number: 2031966-2024-00073
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 02/15/2024
• 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: RELINE FIXATION DEVICES
• Patient Outcome(s): Required Intervention
• Patient Sex: Male