MAUDE Adverse Event Report: NUVASIVE INC.; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

No device could be returned for evaluation as it is still in-situ.Radiographs provided did not confirm the complaint.It is unknown what nuvasive devices were utilized in this case.It is unknown if fusion has been completed.No revision is currently planned as the patient is being evaluated by new surgeons.The patient bone quality is unknown.It is unknown if the patient followed post-operative physical restrictions or suffered a fall.Review of the reported event and provided radiographs identified this patient has had a long history of spinal surgery and we were unable to identify any malfunction in the provided imagery, the root cause could not be determine at this time.Standard labeling for nuvasive posterior fixation lines: ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".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.Nerve damage due to surgical trauma.Bursitis.Dural leak.Paralysis.Death.".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) 2021 we received an email reporting that on unknown dates a male patient underwent 4 lumbar spinal procedures utilizing unknown nuvasive hardware.He is currently in extreme pain from a unknown screw back out in his left hip and is currently being evaluated for revision to remove the nuvasive hardware.After reaching out to him no additional information has been provided.

• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 77475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 12316838
• MDR Text Key: 266361182
• Report Number: 2031966-2021-00094
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• 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 Outcome(s): Other