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

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation as product remains in-situ.Radiographic images confirm alleged event.Even though no product has been returned, review of radiograph suggests the screw was not fully advanced into the lock mechanism.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." ".Warnings, cautions and precautions: if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components.".

Event Description

Patient underwent an anterior lumbar inter body fusion procedure on (b)(6) 2019.Radiographic images indicate screw backing out at s1-l5 levels.No revision procedure is reported at this time nor patient harm reported.

• Brand Name: NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 9624916
• MDR Text Key: 183097612
• Report Number: 2031966-2020-00011
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/08/2020
• 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