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VariLift-L CIE2-15-24-00Recalls & reported problems

Wenzel Spine, Inc. · The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. · Class 2 · Implant

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813210020023), received between Jun 22, 2016 and Jun 22, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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

  • Adverse Event Without Identified Device or Use Problem1
  • Improper or Incorrect Procedure or Method1
  • Malposition of Device1
  • Off-Label Use1

Patient problems

  • Bone Fracture(s)1
  • Hematoma1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 22, 2016Off-Label Use; Improper or Incorrect Procedure or Method; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Malposition of Device; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY TO ADD SUPPLEMENTAL FIXATION FOR PATIENT 3 WEEKS POST VARILIFT-L 2-LEVEL BILATERAL PLIF SURGERY DUE TO WOUND HEMATOMA AND VERTEBRAL FRACTURE. NO DEVICE MALFUNCTION REPORTED.

    Patient problems: Bone Fracture(s); Hematoma

    MAUDE report 5743121 ↗

Other Intervertebral Fusion Device With Bone Graft, Lumbar devices

All Intervertebral Fusion Device With Bone Graft, Lumbar devices →

Sources and updates

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