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

Model Number	2103828
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant was not returned for evaluation.Radiographs confirm that the implant appears to have migrated posteriorly.No further investigation can be completed at this time.It is unclear if the fall contributed to the event, or if the patient complied with post-operative instructions.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: warning, cautions and precautions: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebrae, neurological injury and vascular or visceral injury.Device was not returned.
Event or Problem Description
On (b)(6) 2015 a (b)(6) male was implanted with an expandable lumbar interbody device at l4-l5 and l5-s1.The patient complained of pain after sustaining a fall.Radiographs revealed the device had migrated.The patient was revised on (b)(6) 2015 and the device was replaced with an alternate interbody spacer.

• Brand Name: EXPANDABLE LUMBAR 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: 5362499
• Report Number: 2031966-2015-00092
• Device Sequence Number: 13483797
• Product Code: MAX
• UDI-Device Identifier: 00887517263858
• UDI-Public: 00887517263858
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/12/2016

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: No Information
• Device Model Number: 2103828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR