MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problem Unspecified Infection (1930)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

No product was returned as the involved device remains in situ and no information could be provided confirming the type of infection or its severity.The issue was discovered via a literature review (evaluation of the effectiveness of expandable cages for reconstruction of the anterior column of the spine) and no additional information could be obtained.All nuvasive instrumentation is cleaned and sterilized at the user facility pre case, no sterilization records could be provided.The root cause of the infection could not be confirmed or what the infection was but it is believed to be related to environmental contamination as there was no reported association with the device that currently remains in patient.".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." ".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 and implants are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasives 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))&".

Event Description

On (b)(6) 2016 a female patient underwent a spinal procedure where a cervical spacer was implanted around the l3 level of the spine.Two days later on (b)(6) 2016 the patient underwent a post-op revision to address a migrated cage that was documented in medwatch # (b)(4).Following that procedure the patient experienced a deep posterior wound infection that required revision surgery.On (b)(6) 2016 a revision occurred to address the posterior infection.It is unknown what occurred during the revision but the implanted cage was not reported to have been removed and remains in-situ.Post revision the patient was successfully treated with antibiotics and is reported to be doing well.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12366214
• MDR Text Key: 272898275
• Report Number: 2031966-2021-00108
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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: 08/13/2021
• 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): Required Intervention