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

Model Number	1672392
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor the radiographs were received for review.No information regarding the initial or removal surgery was provided.Root cause has not been determined and no conclusion can be drawn.The patient reportedly requested the explanted device be given to them.The implant is not currently available for evaluation.Review of labeling notes: "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, nonunion or delayed union, fracture of the vertebra, neurological, vascular or visceral injury, metal sensitivity or allergic reaction to a foreign body, infection, decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma, bursitis, dural leak, paralysis and death." device not received.
Event or Problem Description
On (b)(6) 2016 it was reported that a surgeon removed an implant from a patient.No reason for the removal was provided.No other information related to the event was provided.No patient injury was reported.

• Brand Name: AP EXPANDABLE XLIF 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: 6137223
• Report Number: 2031966-2016-00085
• Device Sequence Number: 731309
• Product Code: MAX
• UDI-Device Identifier: 00887517454072
• UDI-Public: 00887517454072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2016

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: 1672392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1