MAUDE Adverse Event Report: WENZEL SPINE, INC. VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE

Model Number	CIE3-10-28-00
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation by manufacturer determined that a consistent lack of adequate disc prep resulted in the device being potentially undersized and not able to gain purchase to the vertebral endplate due to soft tissue.The addition of using a longer length than required by the patient anatomy caused the implant to not seat all the way anterior in the disc space.The device involved in this event was undersized and too long leading to the device potentially migrating or being "loose" in the disc space.The product event is unrelated to a device malfunction or defect.Device not received by manufacturer.
Event or Problem Description
Varilift-lx device migration 2 months post index surgery.

• Brand Name: VARILIFT-LX
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• MDR Report Key: 5880374
• Report Number: 3008009850-2016-00005
• Device Sequence Number: 589935
• Product Code: MAX
• UDI-Device Identifier: 00813210020122
• UDI-Public: 00813210020122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: 02/12/2021
• Device Model Number: CIE3-10-28-00
• Device Lot Number: 08150902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR