L-Varlock Lumbar posterior cage W10 H9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700406328018), received between Apr 23, 2018 and Apr 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K080537); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2018Fracture; Material Torqued; Fracture; Material Torqued

  THE L-VARLOCK EXPANSION SCREW BROKE WHEN THE SURGEON EXPANDED THE CAGE (AT THE BEGINNING OF THE EXPANSION). NO PROBLEM ON THE OTHER SIDE. IT TOOK SOME TIME BEFORE THE SURGEON COULD REMOVE THE BROKEN IMPLANT. THE BROKEN IMPLANT WAS REPLACED BY ANOTHER L-VARLOCK CAGE WITHOUT A PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453333 ↗
• MalfunctionApr 23, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING SURGERY THE SURGEON EXPANDED (MAYBE UP TO MORE THAN 10 TURNS) L-VARLOCK LUMBAR CAGE. THE SURGEON REPORTED THAT HE FELT THE EXPANSION SCREW BROKE SINCE THE SCREWDRIVER KEPT SPINNING. TO DATE WE DO NOT HAVE VISUAL CONFIRMATION THAT THE SCREW BROKE AFTER SEVERAL REQUESTS TO THE SURGEON. SUBMISSION OF A MEDICAL DEVICE REPORT AND THE FDA'S RELEASE OF THAT INFORMATION IS NOT AN ADMISSION THAT A PRODUCT, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR MEDICAL PERSONNEL CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7453331 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080537. One submission often covers many models, so check the product and lot details in each record.

• Z-1461-2017 · Jan 11, 2017 · Terminated
  L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures