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

Model Number	2103424
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirmed interbody implant migration.Examination of the returned explant found no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release and were full functional during inspection.Impact sustained by patient during daily living activities may have contributed to the event.No patient injury was reported.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, nonunion or delayed union, fracture of the vertebra, neurological, vascular or visceral injury." ".The patient's activity level will dictate the longevity of the implant.".
Event or Problem Description
On (b)(6)2017 a patient underwent a lateral interbody fusion with nuvasive cage at l5-s1 levels and another manufacturer's product at l4-l5 levels with no problems reported.Post-operatively the patient suffered a fall followed by back and right leg pain.On (b)(6) 2017 the patient underwent a revision procedure where the cage was removed and replaced with another manufacturer's product.No patient injury reported.

• 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: 6693382
• Report Number: 2031966-2017-00088
• Device Sequence Number: 1246315
• Product Code: MAX
• UDI-Device Identifier: 00887517263841
• UDI-Public: 00887517263841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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: 2103424
• Device Lot Number: BB6767A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/07/2017
• 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