MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 6952810

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

Patient Problems Tissue Damage (2104); Excessive Tear Production (2235); No Code Available (3191)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

No product has been retuned for evaluation as no product malfunction has been alleged.Even though root cause cannot be confirmed, possible patient anatomical condition and/or surgical technique may have contributed to alleged event.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: dural leak." device not returned.

Event Description

A patient underwent spine procedure on (b)(6) 2018.During the procedure it was identified patient had a dural tear.No treatment details provided.

Manufacturer Narrative

Labeling review: ".Preoperative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." h3 other text : no product returned.

• Brand Name: NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9881396
• MDR Text Key: 189218738
• Report Number: 2031966-2020-00059
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K170592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6952810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR