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

Model Number	CIE3-12-24-00
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Inadequate Pain Relief (2388)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation of this event with the information to date suggests that the event (migration and revision) was due to off-label use of the varilift-lx device in a patient with grade 2 or 3 spondylolisthesis.The indications for use and all labeling for the varilift-lx informs users that this device is for use in patients with up to a grade 1 spondylolisthesis.There is no indication of device failure or malfunction.The varilift-lx device was not removed from the patient.
Event or Problem Description
It was reported that a removal of a varilift-lx device was attempted due a reported migration in a patient with grade 2+ spondylolisthesis.

• Brand Name: VARILIFT-LX
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin TX 78753
• MDR Report Key: 7487239
• Report Number: 3008009850-2018-00003
• Device Sequence Number: 2183096
• Product Code: MAX
• UDI-Device Identifier: 00813210020092
• UDI-Public: 00813210020092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: Health Professional
• Device Expiration Date: 12/30/2021
• Device Model Number: CIE3-12-24-00
• Device Lot Number: AF024A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: 61 YR