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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

No device has been returned for evaluation at this time as the device remains in-situ.A lateral radiograph was provided confirming the migrated cage.It is unknown whether the patient experienced any falls or what their post op physical activity levels were.Due to the lack of information provided a root cause could not be determined, but a review of the reported information and similar reported events suggests possible insufficient final torque applied.Rod interference related to insufficient reducing/normalization, implant selection and placement and/or excessive post operative activity as cause or contributors to the event.No lot number could be provided so a review of the manufacturing history could not be performed.No additional investigation can be completed at this time, should more information be received a follow-up report will be completed.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: bending, fracture or loosening of implant component(s), loss of fixation.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.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.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.H3 other text : device not returned, remains in situ.

Event Description

On an unknown date in 2022 a patient underwent a transforaminal lumbar interbody fusion procedure from l4 to s1 utilizing posterior fixation.The surgery was completed without issue.On (b)(6) 2023, during a routine follow up it was discovered via radiograph that two lock screws backed (b)(4) out, resulting in rod separation and both implanted cages migrating anteriorly (b)(4).There is no revision reported as of yet and the patient was not reported to have experienced any adverse consequences as a result of the migrations.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16727197
• MDR Text Key: 313646708
• Report Number: 2031966-2023-00071
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2023
• 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 Sex: Prefer Not To Disclose