CONCORDE LIFT 1978-09-021CRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705034531601), received between Nov 2, 2018 and Mar 9, 2020 — classified as 23 injuries.

The most frequently reported specific device problem is “Collapse” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PERFORMED A REVISION OF CONCORDE LIFT CAGE AND A BROKEN CORTICAL FIX SCREW. THE SURGEON REPLACED THE CAGE AND LEFT THE REMAINING SCREW SHANK IN THE PATIENT AFTER CONFIRMING IT WAS FULLY BURIED IN THE BODY OF L3. THEY BELIEVE THE CAGE LOST SOME HEIGHT AND FAILED TO FUSE. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: 5.5 TI CORT FIX 6X50MM (PART#: 186731650, LOT#: 218438, QUANTITY#: 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9805850 ↗
• InjuryFeb 5, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SPINAL DECOMPRESSION AND LUMBAR POSTERIOR FUSION FROM L4 THROUGH S1 AND WAS IMPLANTED WITH A CONCORDE LIFT EXPANDABLE INTERBODY DEVICE AT L5-S1. ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND PROCEDURE OF THE ANTERIOR LUMBAR INTERBODY FUSION L5-S1 WITH EXPLANTATION OF THE HARDWARE DUE TO DEVICE FAILURE, MIGRATION AND HAS COLLAPSED COMPRESSING THE TRAVERSING S1 NERVE WHICH CAUSED RADICULITIS AND LEG PAIN. PATIENT OUTCOME AND STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) CONCORDE LIFT EXPANDABLE INTERBODY DEVICE CONVEX CAGE 9X21 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nerve Damage; Pain

  MAUDE report 9670632 ↗
• InjuryDec 9, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT HAD A DEPUY SYNTHES SPINE CONCORDE LIFT SPACER COLLAPSE AND RETRO PULSE INTO THE NEURO CANAL AT THE L4/L5 LEVEL. IT IS NOT KNOWN WHY THE IMPLANT COLLAPSED AND RETROPULSION INTO THE PATIENT¿S SPINAL CANAL. IT HAPPENED AT AN UNKNOWN TIME AFTER THE PRIMARY SURGERY TO IMPLANT THE CONCORDE LIFT DEVICE. THE PATIENT WAS EXPERIENCING BACK AND LEG PAIN WHICH LED TO THE PRIMARY SURGERY. THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION TO EXPLANT THE DEFECTIVE DEVICE AND REPLACE IT WITH ADDITIONAL IMPLANTS. THE LIFT SPACER WAS REMOVED THROUGH AN ANTERIOR APPROACH AND REPLACED WITH A SYNFIX EVO SPACER. THE DEVICE WAS DISCARDED. THE PROCEDURE AND PATIENT CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CONCORDE LIFT, CONVEX 9X21. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Code Available

  MAUDE report 9437444 ↗
• InjuryJul 30, 2019Collapse; Collapse

  COLLAPSED HEIGHT OF CONCORDE LIFT CAGE. IF OTHER, DESCRIBE --> TLIF, DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC. REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, (B)(4). DEVICE PROPERTY OF -->PATIENT, DEVICE IN POSSESSION OF -->IMPLANTED. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE. THIS COMPLAINT INVOLVES 1 PRODUCT.

  Patient problems: No Code Available

  MAUDE report 8842392 ↗
• 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 8826028 ↗
• InjuryJul 24, 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 ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8823279 ↗
• InjuryJun 17, 2019Collapse; Collapse

  IT WAS REPORTED ON (B)(6) 2019, AFTER TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT L5-S1 LAST (B)(6) 2019, THE SURGEON CALLED THEN TEXT ME TO INFORM ME THAT THE IMPLANT HAD PARTIALLY COLLAPSED. HE SAID THIS MUST HAVE HAPPENED AFTER THE 2 WEEK FOLLOWUP AS THOSE IMAGES LOOKED FINE, BUT HE REVIEWED THE MORE RECENT FILMS AND NOTICED THE REDUCTION IN HEIGHT. PATIENT HAD NO SYMPTOMS FROM THIS AND HE DOES NOT PLAN TO REOPERATE TO REMOVE THE IMPLANT. HE INFORMED THE PATIENT OF THE RECALL ON THE PRODUCT AS I HAD PREVIOUSLY INFORMED HIM OF THE VOLUNTARY RECALL AT THE TIME OF THE RECALL. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8704854 ↗
• 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 8697924 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED EXPANDABLE CAGE HAS COLLAPSED. AWAITING ADDITIONAL INFORMATION. ON MAY 15 2019 REP RESPONDED WITH PRODUCT CODE.

  Patient problems: No Code Available

  MAUDE report 8658028 ↗
• InjuryMay 31, 2019Collapse; Collapse

  IT WAS REPORTED THAT THERE WAS A CONCORDE LIFT REMOVAL DUE TO COLLAPSED HEIGHT.

  Patient problems: No Code Available

  MAUDE report 8657714 ↗
• InjuryMay 30, 2019Collapse; Collapse

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

  Patient problems: No Code Available

  MAUDE report 8656615 ↗
• InjuryMay 20, 2019Collapse; Collapse

  IT WAS REPORTED THAT TWO CONCORDE LIFT CAGES HAVE COLLAPSED. PATIENT IS IN PAIN. PATIENT HAD SURGERY ON (B)(6) 2018. LIFT CAGES EXPANDED AS INTENDED. FIRST POST OP IMAGES ON (B)(6) 2019 SHOW CAGES WERE STILL EXPANDED. SECONDARY POST OP IMAGES ON (B)(6) 2019 SHOW BOTH CAGES COLLAPSED. THE PATIENT IS COMPLAINING OF PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8624912 ↗
• InjuryMay 20, 2019Collapse; Collapse

  IT WAS REPORTED THAT TWO CONCORDE LIFT CAGES HAVE COLLAPSED. PATIENT IS IN PAIN. PATIENT HAD SURGERY ON (B)(6) 2018. LIFT CAGES EXPANDED AS INTENDED. FIRST POST OP IMAGES ON (B)(6) 2018 SHOW CAGES WERE STILL EXPANDED. SECONDARY POST OP IMAGES ON (B)(6) 2019 SHOW BOTH CAGES COLLAPSED. THE PATIENT IS COMPLAINING OF PAIN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8624812 ↗
• InjuryMay 16, 2019Collapse; Collapse

  IT WAS REPORTED CONCORDE LIFT CAGE COLLAPSE POST OP. THERE IS NO PLAN FOR REVISION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 8618342 ↗
• InjuryApr 4, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT POST OPERATIVELY FELL. AFTER TAKING FOLLOW UP IMAGES CAGE WAS SHOWN TO HAVE RETROPULSED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-00525354. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8484274 ↗
• InjuryApr 4, 2019Collapse; Collapse

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REVISION/REMOVAL SURGERY DUE TO RADICULITIS AND PAIN ON THE BACK. THE PATIENT UNDERWENT INITIAL SURGERY USING CONCORDE LIFT EXPANDABLE INTERBODY DEVICE/DEPUY CONCORD BULLET EXPANDABLE CAGE ON (B)(6) 2018 DUE TO L5-S1 GRADE 1 SPONDYLOLISTHESIS BILATERAL STENOSIS. SHE EXPERIENCED AN INCREASED BACK PAIN UNTIL ON OR ABOUT (B)(6) 2018. X-RAYS WERE THEN TAKEN AND SHOWED SIGNS OF INTERBODY CAGE DISPLACEMENT/POSSIBLE COLLAPSE OF INTERBODY SPACER. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8484060 ↗
• InjuryMar 28, 2019Collapse; Collapse

  THE FOLLOWING WAS REPORTED:IMPLANTED CONCORDE LIFT FOR TWO LEVEL LUMBAR FUSION AT L4-S1. INITIAL CASE WAS ABOUT 4 MONTHS AGO. REVISED CASE TODAY BECAUSE THE CAGE SEEMED COLLAPSE AND BACK OUT. THE CAGE WAS NOT REMOVED BUT IMPACTED AND COMPRESSED DUE TO ANATOMY AND THE DANGER OF PULLING THE CAGE OUT. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE, SEE ABOVE DESCRIPTION, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN,

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8460898 ↗
• InjuryMar 14, 2019Collapse; Collapse

  IT WAS REPORTED CONCORD LIFT CAGE COLLAPSED. HOW IS THE PATIENT? MISERABLE. DOES THE PATIENT HAVE SYMPTOMS ASSOCIATED WITH THE ISSUE? UNKNOWN. IMAGES ¿ ORIGINAL SURGERY AND FOLLOW-UP. IS THERE A PLAN FOR REVISION? YES. IMPLANT PART/LOT NUMBER. 1978-09-021C. IMPLANTATION DATE; FOLLOW-UP DATE. (B)(6) 2018; (B)(6) 2019. SURGEON NAME: DR. (B)(6). NEXT FOLLOW UP PLAN.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8420126 ↗
• InjuryFeb 6, 2019Collapse; Collapse

  THE FOLLOWING WAS REPORTED: PROCEDURE: POSTER SPINE FUSION. I WAS MADE AWARE OF HARDWARE FAILURE BY THE SURGEON AS HE WAS PERFORMING A ROUTINE 2 MONTH PATIENT FOLLOW UP. PATIENT FELT FINE AND WAS UNAWARE UNTIL INFORMED BY THE HCP. NO REVISION SURGERY IS NECESSARY AND NO CUSTOMER FOLLOW UP IS NECESSARY.

  Patient problems: Failure of Implant

  MAUDE report 8311790 ↗
• InjuryDec 21, 2018Collapse; Collapse

  IT WAS REPORTED THAT DR. (B)(6) SENT ME IMAGES FROM HIS PHONE THAT SHOWED THE PROGRESSIVE COLLAPSE OF OUR CONCORDE LIFT IMPLANT, FOLLOWING AN L2-3 TLIF WITH FUSION FROM L2-L5. NO REVISION SURGERY IS PLANNED, THOUGH IT IS POSSIBLE PER DR. (B)(6). PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188965 ↗
• InjuryDec 20, 2018Collapse; Collapse

  THE FOLLOWING WAS REPORTED: SURGERY WENT AS PLANNED, NO ISSUES. SURGEON TEXTED PHOTOS SHOWING IMPLANT HAD COLLAPSED. DO NOT HAVE ADDITIONAL INFORMATION AT THIS TIME

  Patient problems: Failure of Implant; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8186193 ↗
• InjuryDec 19, 2018Migration; Migration

  IT WAS REPORTED THAT THE INTERBODY CAGE PARTIALLY BACKED OUT OF DISC SPACE. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180730 ↗
• InjuryNov 2, 2018Migration; Migration

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT ONE (1) OF THE CONCORDE LIFT CAGES HAS BACKED OUT. PATIENT EXPERIENCED PAIN. IT IS UNKNOWN IF THE PATIENT UNDERWENT A REMOVAL PROCEDURE.

  Patient problems: Pain

  MAUDE report 8034294 ↗

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.