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

Model Number 13550000

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product is still in-situ and could not be returned for evaluation.Images provided confirm the alleged malfunction.The patient was reported as asymptomatic and per surgeon's prerogative, no revision surgery is necessary.It is unknown if the patient followed post-operative restrictions or suffered a fall.It is unknown if delayed or non-union was identified.The root cause cannot be determined however, review of the provided radiographs notes the right side of the construct is unsupported at l4 suggesting possible excessive loading or incomplete final lock down as suspected causes or contributors.No additional investigation can be completed.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: 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.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant.".".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.".

Event Description

On (b)(6) 2020, a patient underwent a spinal surgery with posterior fixation.One month post-op it was discovered via radiographs that there was l5 bilateral loose screws and l5 right rod separation.The patient was reported as asymptomatic and no revision surgery is planned.

• 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: 11167568
• MDR Text Key: 227776402
• Report Number: 2031966-2021-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13550000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• 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
• Patient Age: 43 YR