CONCORDE LIFT 1978-11-023LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034531564), received between Apr 4, 2019 and May 17, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Collapse” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K171425); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2019Collapse; Collapse

  IT WAS REPORTED THAT A LUMBAR FUSION WAS PERFORMED AND A CONCORDE LIFT INTERBODY WAS PLACED IN THE DISC SPACE. A RECENT CT SCAN, FOR AN UNRELATED ISSUE) SHOWED THE CAGE HAD COLLAPSED IN COMPARISON TO THE POST OPERATIVE CT THAT WAS ADMINISTERED.

  Patient problems: Failure of Implant

  MAUDE report 8619639 ↗
• InjuryMay 16, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONCORDE LIFT CAGE WAS LOSING ITS EXPANSION. THE SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGE, HE DOES NOT PLAN TO PERFORM A REVISION SURGERY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8617535 ↗
• InjuryApr 4, 2019Collapse; Collapse

  THE FOLLOWING WAS REPORTED: A CONCORDE LIFT CAGE IMPLANTED (B)(6) 2018. PART NUMBER AND LOT NUMBER UNKNOWN). L5-S1 ISTHMIC SPONDYLOLISTHESIS. 11X23MM CAGE ACHIEVED 4MM OF EXPANSION. IN (B)(6) 2019, THE CAGE PARTIALLY COLLAPSED; THE SURGEON EXPLAINED THAT A LARGE AMOUNT OF BONE WAS USED TO FILL AND BACK FILL THE CAGE DURING PROCEDURE. CT SCAN CONFIRMED PARTIAL FUSION/ BONE SEEN INSIDE AND ACROSS THE IMPLANT. OBESITY WAS NOTED AS A CLINICAL FACTOR.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8484165 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171425. One submission often covers many models, so check the product and lot details in each record.

• Z-1225-2019 · Apr 8, 2019 · Terminated
  Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (U
• Z-0848-2018 · Jul 26, 2017 · Terminated
  Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.