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VariLift-LX CIE3-12-24-00Recalls & reported problems

Wenzel Spine, Inc. · The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-LX is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-LX is designed to be implanted bi-laterally via a PLIF or TLIF approach, and may be implanted with or without supplemental fixation. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813210020092), received between Oct 24, 2017 and Aug 16, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method2
  • Patient-Device Incompatibility2
  • Adverse Event Without Identified Device or Use Problem1
  • Difficult to Remove1
  • Malposition of Device1
  • Migration or Expulsion of Device1
  • Off-Label Use1

Patient problems

  • Pain3
  • Inadequate Pain Relief2

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 16, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION OF A VARILIFT-LX DEVICE WAS PREFORMED DUE TO INTRACTABLE BACK PAIN IN A PATIENT 4 MONTHS POST-OP.

    Patient problems: Inadequate Pain Relief; Pain

    MAUDE report 7791117 ↗
  • InjuryMay 4, 2018Migration or Expulsion of Device; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Migration or Expulsion of Device; Off-Label Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

    IT WAS REPORTED THAT A REMOVAL OF A VARILIFT-LX DEVICE WAS ATTEMPTED DUE A REPORTED MIGRATION IN A PATIENT WITH GRADE 2+ SPONDYLOLISTHESIS.

    Patient problems: Inadequate Pain Relief; Pain

    MAUDE report 7487239 ↗
  • InjuryOct 24, 2017Improper or Incorrect Procedure or Method; Malposition of Device; Improper or Incorrect Procedure or Method; Malposition of Device

    REPORT OF PATIENT REPORTING BACK/LEG PAIN 2 DAYS POST VARILIFT-L SURGERY. SURGEON REPORTS THAT THE DEVICE WAS PLACED TOO FAR LATERAL IN THE INDEX SURGERY REQUIRING REMOVAL OF THE DEVICE.

    Patient problems: Pain

    MAUDE report 6974296 ↗

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Sources and updates

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