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

Model Number	1742606
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation; the explant was discarded at the user facility.Review of event notes from the first revision indicated a size 9mm implant was required per sizing instrumentation, but are available in 8mm and 10mm sizes.The 8mm size was selected, resulting in an undersize condition; subsequent radiographs received confirmed migration into the vertebral foramen that resulted in the first revision on (b)(6) 2016 in which repositioning the 8mm implant was performed.Follow up tradiographs showed that again the implant migrated posteriorly.The second revision took place on (b)(6) 2016; the implant was removed and replaced with another manufacturer's product.The cause of this reported event is related to implant size selection/availability and/or possible anatomical characteristics of the patient.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 discarded by facility.
Event or Problem Description
A (b)(6) male patient underwent a procedure at l4-l5 on (b)(6) 2016.Post -op radiographs showed migration of the interbody.A revision took place on (b)(6) 2016 and the implant was repositioned.Post-op revision radiographs confirmed the device migrated.On (b)(6) 2016 the second revision took place, the devices were removed and replaced.No patient injury was reported and all explants were discarded.

• 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: 6244604
• Report Number: 2031966-2016-00090
• Device Sequence Number: 13556414
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

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: 12/12/2016
• Initial Report FDA Received Date: 01/11/2017
• 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