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

Model Number	5821305
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation a review of the x-ray images confirm the alleged event of migration.As per doctor the right side of l5 level set screw was loose, potentially due to missing the final tightening of previous procedure and/or patient wasn't compliant about post -surgery rehabilitation protocol.Labeling review: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Care should be taken to insure that all components are ideally fixated prior to closure." patient education: ".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." postoperative 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." h3 other text : no product has been returned.
Event or Problem Description
Patient underwent a revision procedure due to cage migration where the set screws and rods were removed and an anterior tlif cage was placed.Patient is reported to be doing well post revision procedure.

• Brand Name: NUVASIVE® TLX INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DDEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7463114
• Report Number: 2031966-2018-00045
• Device Sequence Number: 1146731
• Product Code: MAX
• UDI-Device Identifier: 00887517729811
• UDI-Public: 00887517729811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: Physician
• Device Model Number: 5821305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR