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

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

Patient Problem Numbness (2415)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Review of the reported information states that competitor hardware was used simultaneously with nuvasive hardware which is an off-label use which is most likely the cause and/or contributor of the adverse event.The root cause cannot be determined.No additional investigation can be completed.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include nerve damage due to surgical trauma"."compatibility: unless stated otherwise, nuvasive devices are not to be combined with the components of another system".

Event Description

On (b)(6) 2017 the first part of a two part procedure an extreme lateral interbody fusion was performed at l3/l5.On (b)(6) 2017 the second part of the procedure was conducted a posterior lumbar interbody fusion at l3/s2ai where a competitor's cage was inserted at l5/s.On (b)(6) 2021 a revision surgery was done due to the patient experiencing cauda equina symptoms in the lower right limb.An extreme lateral interbody fusion was performed on l1/l3 and a loose competitor's screw was replaced at t12.It was reported that a competitor's screw was connected with nuvasive hardware during this procedure and t5/t12 is fixed with competitor's products.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 11870427
• MDR Text Key: 252200989
• Report Number: 2031966-2021-00070
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 05/06/2021
• 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
• Patient Age: 69 YR