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

Model Number 11104055

Device Problem Separation Problem (4043)

Patient Problem Pain (1994)

Event Date 02/16/2021

Event Type  malfunction  

Event Description

On (b)(6) 2020 a construct extension was performed to extend a previous t10-s2 up to t3 due to adjacent segment disorder.During the revision surgery, rotating connectors were utilized on the left t10/11 and right t11/12.On an unknown date, an x-ray was taken due to the patient experiencing back pain.The x-ray revealed a lock screw on the connector installed at left t10/11 came off and a rod separation occurred at the connector installed at the right t11/12.On (b)(6) 2021 a revision surgery was performed were the two connectors and two rods were removed and both sides were re-fixed with a single rod.Bone fusion was found to be completed and there was discoloration of tissue found at t9/10.

Manufacturer Narrative

Product not returned as it was discarded by the user facility.No evaluation completed.Radiographs confirm the alleged malfunction.It is unknown if the patient followed post-operative physical restrictions.Torque handle review confirmed product performed within specifications.The root cause cannot be determined at this time.No additional investigation can be completed.Labeling review: ".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: bending, fracture or loosening of implant component(s), loss of fixation." ".Warnings, cautions and precautions: all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.Care should be taken to insure that all components are ideally fixated prior to closure." ".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 even though restrictions in activity are followed." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." device not returned.

Manufacturer Narrative

The device was not received by nuvasive as it was discarded by the user facility however radiographs and photographs of the ex-planted devices were provided confirm the alleged malfunction.It is unknown if the patient followed post-operative physical restrictions.No blood test results provided or conducted.Review of the provided radiographs and photographs of the ex-planted devices identified off-label use of nuvasive connectors as the ifu clearly describes two connectors per side are required for secure construct extension and considered the root cause of the failure resulting in excessive load and subsequent separation.The alleged metallosis was observed as minor discoloration of tissue and appears to be the result of micro-motion between the rod and the lock screw considered by the surgeon to be minor and no blood tests were completed.No additional investigation required.Labeling review: ".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: bending, fracture or loosening of implant component(s), loss of fixation." ".Warnings, cautions and precautions: all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pivoting rod-rod connectors must be used in pairs i.E., two per side." ".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.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 even though restrictions in activity are followed.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11436390
• MDR Text Key: 280451614
• Report Number: 2031966-2021-00038
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517596246
• UDI-Public: 887517596246
• Combination Product (y/n): N
• PMA/PMN Number: K182974
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11104055
• Device Lot Number: AS9123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 13600000; 15460500; 18260002