CONCORDE LIFT 1978-09-023LRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034531571), received between Jan 21, 2019 and Mar 5, 2020 — classified as 14 injuries.

The most frequently reported specific device problem is “Collapse” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PERFORMED A REVISION SURGERY DUE TO THE CONCORD LIFT IMPLANT COLLAPSING. IT WAS ALSO NOTED THAT TWO (2) SCREWS WERE BROKEN AND THOUGHT TO BE CAUSED BY THE COLLAPSING CAGE. THIS WAS DISCOVERED THROUGH A FOLLOW-UP X-RAY WITH THE PATIENT. ALL FOUR (4) OF THE PREVIOUS MATRIX SCREWS WERE REMOVED AND REPLACED WITH FOUR (4) MATRIX SCREW 7X45. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: SCREWS (PART: 04.632.645, LOT: UNKNOWN, QUANTITY: 4), LOCKING CAPS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4), ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2). THIS REPORT IS FOR A CONCORDE LIFT, LORDOTIC 9X23. THIS IS REPORT 1 OF 1 FOR (B)(4). THE BROKEN SCREWS ARE CAPTURED UNDER (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9795233 ↗
• InjuryAug 6, 2019Collapse; Collapse

  IT WAS REPORTED ON JULY 11, 2019, THE CONCORDE LIFT EXPANSION CAGE IS LOSING ITS EXPANSION. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. AT THIS TIME THE SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8864621 ↗
• InjuryAug 6, 2019Collapse; Collapse

  IT WAS REPORTED ON (B)(6) 2019, THE CONCORDE LIFT EXPANSION CAGE IS LOSING ITS EXPANSION. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. AT THIS TIME THE SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. PATIENT CONSEQUENCE IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8864493 ↗
• InjuryJul 25, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FOLLOW UP FILMS SHOW THAT THE CONCORDE LIFT EXPANDABLE CAGE WAS LOSING ITS EXPANSION. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8826059 ↗
• InjuryJun 26, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING UNKNOWN PROCEDURE, THE CONCORDE LIFT CAGE COLLAPSED. PATIENT IS ASYMPTOMATIC, BUT THE COLLAPSE WAS NOTICED WHEN COMPARING INTRA-OP PICTURES WITH THE POST-OP FOLLOW UP FILMS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8735931 ↗
• InjuryJun 13, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER SPINAL FUSION PROCEDURE PATIENT HAS PROBABLE PARTIAL COLLAPSE OF CONCORDE LIFT IMPLANT. SURGEON NOTICED AT FOLLOW UP APPOINTMENT ON (B)(6) 2019 THAT THE PATIENT HAS NEW SLIGHT BACK PAIN AND LOOKED FUSED, BUT NO NEW LEG PAIN WHICH HE HAD BEFORE SURGERY. SURGEON PLANS TO CONTINUE FOLLOW UP AND REEVALUATE AT NEXT VISIT. PROCEDURE OUTCOME AND PATIENT CONSEQUENCE ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8698038 ↗
• InjuryJun 13, 2019Collapse; Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER SPINAL FUSION PROCEDURE, WHILE THE PATIENT HAD A FOLLOW-UP VISIT WITH THE SURGEON, THE PATIENT DESCRIBES A ¿CLICKING¿ SOUND OR SENSATION WHILE BENDING. THE SURGEON DESCRIBES A LOSS OF HEIGHT OF THE L5-S1 CAGE. FURTHER ANALYSIS REQUIRED TO DETERMINE WHICH CAGE IS AT THE L5-S1 LEVEL. THE SURGEON PLANS TO CONTINUE TO EVALUATE THE PATIENT AT THIS TIME. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8697860 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED CONCORDE LIFT CAGES ARE LOSING ITS EXPANSION. AT THIS TIME, SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8657940 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED CONCORDE LIFT CAGES ARE LOSING ITS EXPANSION. AT THIS TIME, SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8657892 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED, CONCORDE LIFT CAGES ARE LOSING IT'S EXPANSION. AT THIS TIME, SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8657798 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED, CONCORDE LIFT CAGES ARE LOSING IT'S EXPANSION. AT THIS TIME, SURGEON INTENDS TO MONITOR THE PATIENT AND IF NOTHING CHANGES DOES NOT PLAN TO PERFORM A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8657772 ↗
• InjuryMar 1, 2019Collapse; Migration; Collapse; Migration

  IT WAS REPORTED BY SURGEON, THAT THE CONCORDE LIFT CAGE APPEARED TO HAVE COLLAPSED AND SUBSIDED ON FOLLOW UP X-RAYS. 2-3 MONTHS POST-OP. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8383507 ↗
• InjuryMar 1, 2019Collapse; Collapse

  IT WAS REPORTED DURING A ROUTINE FOLLOW UP VISIT, AN X-RAY WAS PERFORMED AND SHOWED THE CAGE HAD COLLAPSED. NO REVISION IS SCHEDULED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8383005 ↗
• InjuryJan 21, 2019Collapse; Collapse

  IT WAS REPORTED DR (B)(6) ((B)(6) HOSPITAL IN (B)(6) SENT (B)(6) (SR. SALES CONSULTANT, (B)(6) IMAGES FROM A SIX-MONTH FOLLOW-UP ON (B)(6) 2018 THAT SHOWED A POTENTIAL COLLAPSE OF A LORDOTIC CONCORDE LIFT IMPLANT. THE IMPLANT IN QUESTION IS AT THE L4-L5 LEVEL OF A 2-LEVEL TLIF L4-S1 THAT WAS COMPLETED IN LATE (B)(6) 2018. PATIENT IS CURRENTLY EXPERIENCE AXIAL BACK PAIN WITH NO RADICULAR PAIN. NO REVISION SURGERY IS PLANNED AS OF NOW, DR (B)(6) PLANS TO MONITOR THE PATIENT FOR A FEW MORE MONTHS AND GO FROM THERE. ATTACHED IS AN IMAGE COMPARING THE 2-WEEK FOLLOW-UP X-RAY ON (B)(6) 2018 (LEFT) TO THE 6-MONTH FOLLOW-UP X-RAY ON (B)(6) 2018 (RIGHT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8264785 ↗

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.