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

Model Number	1742618
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was left in patient and no revision occured or is planned at this time so no material will be returned to evaluate.Review of films corroborated the reported migration event.The implant was noted to have subsided into the upper endplate; it is not known if the subsidence resulted from or contributed to the migration.No information is known related to bone integrity or patient activity which may have contributed to the event.Labeling review: ifu 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" implant left in patient.
Event or Problem Description
On "(b)(6) 2017" a (b)(6) year-old female patient underwent a 5-level procedure from l2-s1.The patient returned to the clinic for routine 6-week follow up and it was discovered via radiograph that the implant at the l2/3 level migrated posteriorly.The patient is currently asymptomatic and no action or revision is planned 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: 6436618
• Report Number: 2031966-2017-00025
• Device Sequence Number: 986818
• Product Code: MAX
• UDI-Device Identifier: 00887517670816
• UDI-Public: 00887517670816
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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

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: 1742618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR