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

Model Number	1742606
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation; the interbody device was repositioned.Review of event notes indicated a size 9mm implant was required per sizing instrumentation, but are available in 8mm and 10mm sizes.The 10mm was recommended but surgeon preference was to use the 8mm.Radiographs received confirmed migration into the vertebral foramen.The cause of this reported event is related to implant size selection and possible anatomical characteristics of the patient.The revision procedure to reposition the migration was completed on (b)(6) 2016 without issue or patient injury.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." "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." device remains in-situ.
Event or Problem Description
A (b)(6) male patient underwent a procedure at l4-l5 on (b)(6) 2016.Post-operative radiographs showed the implant migrated into the foramen.The patient was complaining of pain.A revision took place on (b)(6) 2016 in which the implant was repositioned.No patient injury was reported.

• 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: 6025015
• Report Number: 2031966-2016-00074
• Device Sequence Number: 55125
• Product Code: MAX
• UDI-Device Identifier: 00887517670694
• UDI-Public: 00887517670694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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: 1742606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR