VariLift-LX CIE3-10-28-00Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813210020122), received between May 17, 2016 and Jan 31, 2017 — classified as 5 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (5 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
- Migration or Expulsion of Device5
- Improper or Incorrect Procedure or Method2
- Malposition of Device1
- Off-Label Use1
Patient problems
- Inadequate Pain Relief5
- Fall1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
REPORT OF VARILIFT LX DEVICE MIGRATION 6 WEEKS POST-OP.
Patient problems: Fall; Inadequate Pain Relief
MAUDE report 6290259 ↗InjuryJan 12, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
A REMOVAL OF A VARILIFT-LX DEVICE WAS REPORTED DUE TO POSSIBLE MIGRATION 6 MONTHS POST INDEX SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 6247882 ↗InjuryAug 16, 2016Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method
VARILIFT-LX DEVICE MIGRATION 5 MONTHS POST INDEX SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 5880380 ↗InjuryAug 16, 2016Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method
VARILIFT-LX DEVICE MIGRATION 2 MONTHS POST INDEX SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 5880374 ↗InjuryMay 17, 2016Migration or Expulsion of Device; Off-Label Use; Malposition of Device; Migration or Expulsion of Device; Off-Label Use; Malposition of Device
REPORT OF REMOVAL SURGERY SCHEDULED FOR VARILIFT LUMBAR DEVICE APPROXIMATELY 6 WEEKS POST-OP. INVESTIGATION IS IN PROGRESS.
Patient problems: Inadequate Pain Relief; Pain
MAUDE report 5659378 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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