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

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction was alleged.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." product not returned.

Event Description

On an unknown date patient underwent a spinal procedure.During a follow up visit a deep wound infection with wound drainage was reported.As per reporter, on (b)(6) 2019 the infection was treated with an incision and debridement.

• Brand Name: NUVASIVE XLX 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: virnalisa cobacha ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 9887179
• MDR Text Key: 189220279
• Report Number: 2031966-2020-00061
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/26/2020
• 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): Hospitalization; Other
• Patient Age: 67 YR