MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8800000006

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not returned for evaluation.Photographs were provided, however we were unable to confirm the alleged event.Review of the complaint report states patient suffered a substantial fall where the device was expelled as a result of the excessive force of the fall.No product failure was alleged or identified.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, dislocation and migration.".

Event Description

It was reported patient suffered a fall on (b)(6) 2019 and the lock screw at l5 level and rod came off.On (b)(6) 2020 patient underwent a revision procedure where the set screw was replaced.

Event Description

Updated investigation findings.

Manufacturer Narrative

The device was returned for evaluation though no radiographs were received.Examination of the returned lock screw identified damage created by micro-motion indicated by the sections where the rod rubbed back and forth against the lock screw and created a groove or wear mark.This lock screw shows four such grooves indicating two distinct positions where the rod rubbed,indicating it was backing out prior to any separation.Also observed was a tiny section of damage to the first helical flange which suggests only one thread was engaged when the lock screw was forced out of the tulip, possibly during the patient fall.The root cause appears to be rod interference during final tightening.The fall was most likely a secondary event that possibly forced out the already loose lock screw or simply initiated the evaluation that discovered the previously backed out lock screw.Torque handle utilization was not identified in the case.Labeling review: ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.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, fracture of the vertebra, neurological, vascular or visceral injury, metal sensitivity or allergic reaction to a foreign body, infection, decrease in bone density due to stress shielding, 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." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".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." ".Failure to verify screw height following insertion may result in screw heights not matching lordosis of the patient.All heights of screws should match with patient¿s lordosis to facilitate the best rod normalization when securing lock screws." ".Failure to final-tighten the lock screws with the counter-torque and torque t-handle may result in rod not able to normalize to the tulip.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set.".

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9623384
• MDR Text Key: 177134725
• Report Number: 2031966-2020-00010
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517103482
• UDI-Public: 887517103482
• Combination Product (y/n): N
• PMA/PMN Number: K121619
• 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: 06/10/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8800000006
• Device Lot Number: N237368
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8827540006
• Patient Outcome(s): Hospitalization; Required Intervention