CONCORDE LIFT 1978-09-026CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034531526), received between Jul 17, 2018 and Feb 6, 2020 — classified as 2 injuries, 1 malfunction.

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

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.

• InjuryFeb 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD THE CAGE COLLAPSE. WHEN THE CAGE WAS REMOVED IT WAS COLLAPSED TO THE ORIGINAL HEIGHT. THE PATIENT HAD PSEUDOARTHROSIS AT THE L45 LEVEL. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE CONCORDE LIFT, CONVEX 9X26. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9678301 ↗
• InjuryApr 4, 2019Migration; Migration

  IT WAS REPORTED THAT THE INTERBODY CAGE RETROPULSED. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. 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? UNKNOWN. 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. (B)(4). 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; Unspecified Infection

  MAUDE report 8484320 ↗
• MalfunctionJul 17, 2018Break; Break

  THE SURGEON WAS ATTEMPTING TO REMOVE THE TLIF SPACER FRO L5-S1. IT HAS ONLY BEEN INSERTED HALF WAY INTO THE SPACE WHEN HE WENT TO REMOVE IT, THE BACK OF THE IMPLANT BROKE OFF. AFTER ATTEMPTED DISTRACTION TO REMOVE THE IMPLANT THE SURGEON USED A TAMP TO ADVANCE THE IMPLANT INTO THE DISC SPACE AND ACHIEVED THE NEEDED DISTRACTION. PATIENT CONSEQUENCE? NO. PATIENT CONSEQUENCE DESCRIPTION: NOTHING. 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 7695531 ↗

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.