MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE 4.5-5.0 SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 13450000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Radiographs provided confirmed the alleged event.It is unknown if patient followed post-operative activity restrictions.The root cause of the loose screw is unknown at this time.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.Potential risks identified with the use of this system, which may require additional surgery, include loosening of implant component(s), loss of fixation, nonunion or delayed union." warnings, cautions and precautions: "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." post-operative warnings: "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".

Event Description

On (b)(6) 2019, a patient underwent a spinal procedure without any reported issues.During a routine follow up, radiograph images identified a loose set screw.On (b)(6) 2019, a revision procedure was performed where the screws were replaced.No patient injury reported.

Manufacturer Narrative

The device was received along with radiographs that confirmed the alleged event.Examination of the returned lock screw found a lack of marking consistent with final torque off, the inferior surface reveled light scratching and a slight trough consistent with rubbing against the rod while loosening.The threads and the internal hex feature are pristine no damage observed.No torque device was confirmed utilized nor has one been provided for examination.Even though the root cause cannot be confirmed, the event is suspected to be a lack of final torque pressure that is either the result of an out of range torque device or fan incomplete final torque off.

Event Description

Reference section h10 for device evaluation.

• Brand Name: NUVASIVE RELINE 4.5-5.0 SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9194133
• MDR Text Key: 163157657
• Report Number: 2031966-2019-00244
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517766021
• UDI-Public: 887517766021
• Combination Product (y/n): N
• PMA/PMN Number: K170126
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13450000
• Device Lot Number: SA2904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1