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

Model Number	4103424
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs of the interbody device pre- and post-patient fall as well as revision were received and reviewed confirming the migration.It is known the patient incurred a fall down a flight of stairs that caused or contributed to the migration of the device.The returned device was inspected and no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.No malfunction of the device has been identified.The root cause of this reported event appears be related to an impact sustained during activities of daily living.No patient injury has been reported.
Event or Problem Description
On (b)(6) 2016 a (b)(6) y/o woman received an expandable interbody with bilateral posterior pedicle screw fixation at s1-l3 without issue.On an unknown date the patient suffered a fall down a flight of stairs, radiographs verified the implant migrated laterally.A revision was completed on (b)(6) 2017 during which the implant was replaced without issue.

• 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: 6390044
• Report Number: 2031966-2017-00016
• Device Sequence Number: 536893
• Product Code: MAX
• UDI-Device Identifier: 00887517265357
• UDI-Public: 00887517265357
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: 4103424
• Device Lot Number: ST53846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR