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

Model Number 16026545

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was reported to nuvasive by the patients lawyer and no product was returned for evaluation and no radiographs or images were provided to confirm the alleged failure.It is unknown if the fusion was achieved.It is unknown if patient followed post-operative physical restrictions or suffered a fall.Due to lack of information the root cause is undetermined.No additional investigation can be completed at this time.Labeling review: potential adverse events and complications: infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels, spinal cord or peripheral nerves; and permanent pain.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, nonunion or delayed union, pain, discomfort or abnormal sensations due to the presence of the device.Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.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.The patient must be made aware that implant components may bend, break or loosen.Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications.

Event Description

On (b)(6) 2017 a minimally invasive lumbar interbody fusion was performed at l3-s1.An x-ray on (b)(6) 2018 revealed broken right pedicle screw at s1.The patient reportedly has back pain and is required to undergo a revision surgery to attempt to alleviate the pain.

• 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: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10944197
• MDR Text Key: 219514839
• Report Number: 2031966-2020-00213
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517556639
• UDI-Public: 887517556639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16026545
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2020
• 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