CONCORDE LIFT 2878-90-010Recalls & reported problems
Medos International Sàrl · CONCORDE LIFT INSTRUMENTS TORQUE LIMITING PALM HANDLE · Class 1
All models of CONCORDE LIFT (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034506968), received between May 30, 2018 and Apr 29, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 reports).
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
Device problems
- Mechanical Problem3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED WHILE WE WERE EXPANDING THE LIFT CAGE, THE SURGEON NOTICED THAT THE HANDLE WAS NOT TORQUING OUT. APPEARED THAT THE CAGE HAD REACHED ITS MAXIMUM HEIGHT BUT THE HANDLE WAS JUST TURNING. HE CONTINUES TURNING AND IT FINALLY TORQUED OUT. THE ENTIRE EPISODE LASTED 15-20 SECONDS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8560049 ↗MalfunctionSep 28, 2018Mechanical Problem; Mechanical Problem
WE WERE WORKING WITH CONCORDE LIFT, DOING A MIS TLIF. THE PRODUCT TORQUED OFF AFTER MINIMAL CAGE DISTRACTION PATIENT CONSEQUENCE? NO. 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 7920339 ↗MalfunctionMay 30, 2018Mechanical Problem; Mechanical Problem
SURGEON SHEARED OFF THE END OF THE TORQUE DRIVER WHEN TORQUEING OUT THE CONCORDE LIFT IMPLANT. AFTER INSERTION THE SURGEON IMPACTED THE IMPLANT INTO THE L4/5 DISC SPACE. WITH THE IMPLANT INSERTION DEVICE ON THE SURGEON THEN TRIED TO EXPAND THE DEVICE. THEN HE REMOVED THE INSERTION DEVICE AND TRIED TO FINAL TORQUE THE IMPLANT WITHOUT THE IMPLANT HOLDER ON AND THE DRIVER TIP BROKE OFF WITHOUT TORQUEING OUT. THE SURGEON THEN SUCTIONED OUT THE BROKEN END OF THE TIP, AND LEFT THE IMPLANT IN THE SPACE AND COMPRESSED ON THE SCREWS ABOVE AND BELOW. PATIENT CONSEQUENCE? :NO. 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 7554481 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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