MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE TLX INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	5902826P2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was called reported by the patient and radiographs provided confirmed the complaint.The removed ex-plant was not available for examination.Review of the reported event notes that 4 months post-op the migration took place with the patient being reported as non-physically active.No root cause can be determined, incomplete deployment, placement and or sizing are suspected as cause or contributors.No additional investigation could be completed.Labeling review: "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.Neurological, vascular or visceral injury.Pain, discomfort or abnormal sensations due to the presence of the device." "warnings, cautions and precautions: warnings, cautions and precautions: the subject device is intended for use only as indicated.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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone"."patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.Additional care should be taken to ensure a thorough discectomy is completed in order to correctly size, place, and expand the device.An incomplete discectomy may result in difficulty to fully deploy and place the device in its intended position." "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 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 or Problem Description
A revision took place on (b)(6) 2020 and the cage was replaced without a reported issue.On another unknown date experiencing extreme pain again , radiographs again show the cage at l2-3 had migrated.On (b)(6) 2021 a revision procedure was completed replacing the cage at l2-3 and adding additional posterior fixation.

• Brand Name: NUVASIVE TLX INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 11329980
• Report Number: 2031966-2021-00030
• Device Sequence Number: 16431992
• Product Code: MAX
• UDI-Device Identifier: 00887517958365
• UDI-Public: 887517958365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5902826P2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR