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

Model Number 6081023P2

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation as product remains in-situ.No radiographs were provided to confirm the alleged event.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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 even though restrictions in activity are followed.".

Event Description

It was reported that the set screw had loosened and the cage was backed out.As per reporter patient is asymptomatic and there is no plan for a revision procedure at this time.

Event Description

On (b)(6) 2019, patient underwent a posterior lumbar inter-body fusion procedure without any issue.On (b)(6) 2019 during a follow up a loose set screw was observed at left l4 level and a cage back out at l4-5.On (b)(6) 2019, patient underwent a revision procedure where the set screw, pedicle screw at left l4 and the left rod were all replaced.The backed out cage was re-inserted to l4-5.

Manufacturer Narrative

Images of the screw, lock screw and rod were provided along with 5 radiographs.Even though no product was returned images provided were used to confirm the alleged event.Based on the provided images, the potential root cause may be related to procedural error related to rod/lock screw normalization and final tightening.No additional investigation possible.No patient injury reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9438822
• MDR Text Key: 183098153
• Report Number: 2031966-2019-00262
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• PMA/PMN Number: K190636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6081023P2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 11355070; 16027550; 6081023P2
• Patient Age: 57 YR