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

Model Number	8123828
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of radiographs received indicates the interbody device appears to have subsided into the posterior portion of the l5 vertebral body.No trauma or impacts have been reported.It is unclear if the patient has complied with post-operative care instructions and/or mobility limitations.It is not known if the patient has sufficient bone integrity.Construct revision is reportedly expected but has not yet occurred.Labeling review: "contraindications include but are not limited to:." ".Patients with inadequate bone stock or quality." ".Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications." device not explanted.
Event or Problem Description
Seven months following implantation of an interbody spacer with unilateral posterior fixation in (b)(6) 2015, the patient reported having radicular symptoms.Review of radiographs suggested the possibility of implant migration.No injury has been reported and no surgical revision of the construct has occurred as of the report date.
Additional Manufacturer Narrative
Supplemental report submitted to initial part number provided was not correct.Product was returned tested and alleged failure could not be duplicated.
Additional Manufacturer Narrative
Supplemental report has been submitted to add the lot code number.

• 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: 5854555
• Report Number: 2031966-2016-00062
• Device Sequence Number: 463623
• Product Code: MAX
• UDI-Device Identifier: 00887517265357
• UDI-Public: 00887517265357
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2018

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: 8123828
• Device Lot Number: TU4244
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2016
• Supplement Date Received by Manufacturer: 11/28/2016; 11/28/2016
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 01/04/2018; 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1