MAUDE Adverse Event Report: VERTEBRAL TECHNOLOGIES INC. INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE

Model Number	9076-12-20-5
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented at approximately one month post-op with pain.Imaging revealed fusion construct failure, both screws (screws not provided by vti) and interbody.The doctor stated the patient was high risk (high bmi and osteopenic bone).Screws and interbody were revised.A review of the images showed the second b module is no longer locked to the first b module and has migrated, with attached c module, about 10mm posteriorly.In addition, the device is rotated slightly in the disc space.

• Brand Name: INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
• Common Device Name: INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): VERTEBRAL TECHNOLOGIES INC.; 13845 industrial park blvd; minneapolis MN 55441
• MDR Report Key: 6558966
• Report Number: 3007617183-2017-00001
• Device Sequence Number: 16166885
• Product Code: MAX
• UDI-Device Identifier: 00819475010113
• UDI-Public: 00819475010113
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: 9076-12-20-5
• Device Catalogue Number: 9076-12-20-5
• Device Lot Number: 120705-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 136