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

Model Number	5841305
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned for evaluation as it remains in-situ.Radiographs were reviewed and confirm the event.Potential adverse events and complications "as with any major surgical procedures, there are risks involved in surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: bending, fracture or loosening of implant component(s).Pain, discomfort or abnormal sensations due to the presence of the device." "if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." remains in-situ.
Event or Problem Description
Received information stating patient underwent posterior lateral fusion on (b)(6) 2017.Two months post-operative, radiographs indicate the transforaminal lordotic expandable (tlx) implant migrated posteriorly.Patient is symptomatic, revision surgery has not been scheduled at this time.

• 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: 6721798
• Report Number: 2031966-2017-00092
• Device Sequence Number: 18887049
• Product Code: MAX
• UDI-Device Identifier: 00887517730015
• UDI-Public: 00887517730015
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: No Information
• Device Model Number: 5841305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 109