CONCORDE LIFT 2878-04-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034531236), received between Jun 12, 2018 and Mar 6, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (12 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT THE EXPANSION DRIVER TIP BROKE AND WE WERE UNABLE TO USE IT TO EXPAND THE LIFT CAGE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NA, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8396483 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED DURING THE CASE THE REASON CONCORDE LIFT EXPANDABLE INTERBODY CAGE, PHYSICIAN WANTED TO REPOSITION THE CAGE. IT WASN'T DONE FAR OFF, SO HE COLLAPSED AND WHILE HE IS ATTEMPTING TO COLLAPSE THE CAGE ABOUT HALFWAY THROUGH THE DRIVER TIP (2878-04-101) BROKE OFF INSIDE THE IMPLANT. WE WERE ABLE TO FULLY COLLAPSE THE IMPLANT AND REMOVED THE IMPLANT (1978-09-021C). WE USED ANOTHER IMPLANT AND A FRESH DRIVER AND WERE FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333105 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE CONCORDE LIFT DRIVER (287804101) BROKE OFF WHEN THE SURGEON WAS TRYING TO GET ADDITIONAL EXPANSION. THE SURGEON HAS USED THE DEVICE SEVERAL TIMES AND IS FAMILIAR WITH THE TORQUE OUT DESIGN BUT WAS TRYING TO GET ADDITIONAL EXPANSION AFTER TORQUE OUT WHEN THE TIP OF THE DRIVER SHAFT BROKE OFF IN THE IMPLANT. THERE WAS NO NEGATIVE CONSEQUENCE TO THE PATIENT DURING THE CASE BECAUSE OF THIS. CLINICAL GOALS WERE ACHIEVED. 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 8165992 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED THAT THE TIPS BROKE OFF ON TWO CONCORDE LIFT DEVICES DURING A L5-S1 TLIF ON (B)(6) 2018. AS THE SURGEON WAS POSITIONING THE DEVICE IN THE L5-S1 DISC SPACE, THE DRIVER TORQUED OUT. THE SURGEON THEN TOOK A NEEDLE DRIVER AND FURTHER TURNED THE DRIVER PAST ITS TORQUE LIMIT, AND THE TIP SNAPPED OFF. THE TIP REMAINED IN THE IMPLANT. THE SURGEON PULLED THE DRIVER OUT AND WAS FINISHED WITH THAT PORTION OF THE CASE. THE SURGEON THEN MOVED TO ANOTHER LEVEL, AT L4-L5. THE SURGEON WANTED MORE DISTRACTION, SO HE USED ANOTHER OF THE SAME TYPE OF DRIVER. HE TOOK A HEAVY NEEDLE DRIVER TO GET MORE DISTRACTION AND THE TIP OF THE SECOND DRIVER ALSO BROKE. THE BROKEN TIP OF THE SECOND DEVICE REMAINS IN THE IMPLANT AT L4-L5. THERE WAS NO REPORTED SURGICAL DELAY, NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7804389 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED THAT THE TIPS BROKE OFF ON TWO CONCORDE LIFT DEVICES DURING A L5-S1 TLIF ON (B)(6) 2018. AS THE SURGEON WAS POSITIONING THE DEVICE IN THE L5-S1 DISC SPACE, THE DRIVER TORQUED OUT. THE SURGEON THEN TOOK A NEEDLE DRIVER AND FURTHER TURNED THE DRIVER PAST ITS TORQUE LIMIT, AND THE TIP SNAPPED OFF. THE TIP REMAINED IN THE IMPLANT. THE SURGEON PULLED THE DRIVER OUT AND WAS FINISHED WITH THAT PORTION OF THE CASE. THE SURGEON THEN MOVED TO ANOTHER LEVEL, AT L4-L5. THE SURGEON WANTED MORE DISTRACTION, SO HE USED ANOTHER OF THE SAME TYPE OF DRIVER. HE TOOK A HEAVY NEEDLE DRIVER TO GET MORE DISTRACTION AND THE TIP OF THE SECOND DRIVER ALSO BROKE. THE BROKEN TIP OF THE SECOND DEVICE REMAINS IN THE IMPLANT AT L4-L5. THERE WAS NO REPORTED SURGICAL DELAY, NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7804371 ↗
• MalfunctionAug 16, 2018Break; Break

  WHEN INSERTING A CONCORDE LIFT CAGE (ITEM NUMBER 1978-09-021C), DR. (B)(6) TURNED THE EXPANSION KNOB IN A COUNTERCLOCKWISE DIRECTION TO COLLAPSE THE CAGE. DR. (B)(6) APPLIED A SIGNIFICANT AMOUNT OF FORCE IN THIS MOTION CAUSING THE TIP OF THE SCREW DRIVER SHAFT (ITEM 2878-04-101) TO BREAK. UPON REALIZING THIS, DR. (B)(6) REMOVED THE IMPLANT AND REMOVED THE BROKEN TIP. WE READJUSTED THE TETHER INSTRUMENT AND SWAPPED OUT THE SCREW DRIVER. THE IMPLANT WAS THEN REINSERTED AND EXPANDED PROPERLY. IT IS IMPORTANT TO NOTE THAT THE BROKEN PIECE WAS IN FACT RETRIEVED AND NO PARTS REMAINED IN THE PATIENT. PATIENT CONSEQUENCE? :NO. CONCOMITANT PART: 1978-09-021C, QUANTITY 1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788466 ↗
• MalfunctionAug 9, 2018Break; Break

  CONCORDE LIFT EXPANSION DRIVER TIP BROKE IN THE IMPLANT SO THAT THE IMPLANT COULD NOT BE EXPANDED. WE HAD TO REMOVE THE IMPLANT AND USE A NEW ONE WITH A REPLACEMENT DRIVER SHAFT. PATIENT WAS NOT AFFECTED. PATIENT CONSEQUENCE? NO. PATIENT CONSEQUENCE DESCRIPTION:NO PATIENT CONSEQUENCE. ACTION TAKEN FOR PROCEDURE: WASTED ONE IMPLANT AND REPLACED WITH ANOTHER (B)(4). 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 7769020 ↗
• MalfunctionJul 24, 2018Break; Break

  IT WAS REPORTED DRIVER TIP BROKEN DURING PROCEDURE. NO ADVERSE CONSEQUENCE TO PATIENT. LESS THAN 5 MINUTE DELAY REPORTED. NO FRAGMENTS LEFT IN PATIENT. DETAILS FROM SALES REP: THE DAY BEFORE THE CASE REP MADE SURE TETHER WAS NOT STUCK. ACCESS AND PREP WAS FINE. CAGE WAS OPENED AND LOADED ON INSERTER, PUT IN DISC SPACE, THEN EXPANDED CLOCKWISE AND IT TORQUED OUT IMMEDIATELY. REP THINKS THE TETHER WAS STUCK AT ZERO AND THIS OCCURRED EITHER ON THE BACK TABLE OR THE SURGEON TURNED CCW AND JAMMED IT JUST BEFORE TRYING TO EXPAND. SURGEON USED A KELLY TO TRY AND BREAK IT FREE, BUT CONFUSED CW AND CCW, AND SURGEON CRANKED ON IT CCW ACCIDENTALLY. COULDN'T MAKE IT TURN CW AFTER THIS WITH KELLY. SURGEON THEN GRABBED ANOTHER GRABBING TYPE INSTRUMENT (AS SALES REP WAS LOOKING FOR PLIERS) AND THE DRIVER TIP BROKE WHEN TETHER BROKE FREE. SALES REP IS NOT SURE IF IT WAS GOING CW OR CCW WHEN IT BROKE BECAUSE HE DID NOT SEE IT HAPPEN AS HE WAS LOOKING FOR PLIERS WHEN IT OCCURRED. SURGEON WAS EASILY ABLE TO REMOVE IMPLANT, WHICH WAS STILL FULLY COLLAPSED. REPLACED WITH SECOND DRIVER AND ANOTHER IMPLANT, WHICH EXPANDED IN THE SAME SPACE JUST FINE. PROCEDURE WAS THEN COMPLETED JUST FINE, BOTH LEVELS WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714124 ↗
• MalfunctionJun 25, 2018Break; Break

  IT WAS REPORTED THAT AT THE (B)(6) HOSPITAL, DR. (B)(6) CONCORDE LIFT LORDOTIC EXPANDABLE CAGE WAS USED AT L1-L2 LEVEL TO CREATE LORDOSIS IN A PATIENT WITH SEVERE FLAT BACK. THE DISC SPACE WAS CREATED USING SHAVERS AND THEN PITUITARIES AND CURETTES. WE WERE ABLE TO GET A 10 MM SHAVER IN THE DISC SPACE AND THEN A LORDOTIC TRIAL FOR THE 10 MM HEIGHT OF THE CONCORDE LIFT LORDOTIC CAGE. THE IMPLANT WAS INSERTED IN THE DISC SPACE AND THE DRIVER SHAFT WAS THEN INSERTED INTO THE INSERTION HOLDER. DRIVER SHAFT WAS CLEARLY INSERTED INTO DEVICE DEMONSTRATED BY THE LINE ON THE SHAFT. DRIVER HANDLE IMMEDIATELY TORQUED OUT AS DISC SPACE WAS TIGHT TO BEGIN WITH. DOCTOR HELD HANDLE AND TOP PART OF DRIVER SHAFT AND TURNED AGAIN. AT THIS POINT THE DRIVER EXPANSION TIP BROKE OFF AT DISTAL END. ABOUT 1-2 MM OF THE DISTAL TIP. WE WERE ABLE TO REMOVE DRIVER FRAGMENT EASILY WITH SUCTION AND THEN TRIED AGAIN WITH BACK-UP DRIVER SHAFT. AGAIN, HANDLE IMMEDIATELY TORQUED OUT WITH NO EXPANSION. DISC SPACE WAS TIGHT TO BEGIN WITH SO NO SURPRISE. NO HARM WHATSOEVER TO PATIENT AND NO DELAY TO THE CASE. BROKEN DRIVER SHAFT WAS SET ASIDE FOR RETURN BUT WAS THEN MISTAKENLY DISCARDED BY SURGICAL SCRUB TECH AFTER TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635396 ↗
• MalfunctionJun 21, 2018Break; Break

  THE TIP OF THE CONCORDED LIFT EXPANSION DRIVER BROKE OFF DURING EXPANSION. PATIENT CONSEQUENCE? : NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Local Reaction

  MAUDE report 7625274 ↗
• MalfunctionJun 13, 2018Break; Break

  IT WAS REPORTED SURGEON INSERTED THE LIFT CAGE INTO THE DISC SPACE, THE INSERTER WAS AT ZERO. HE INSERTED THE DRIVER SHAFT, STARTED TO TURN THE HANDLE AND IT WAS EASY FOR HIM TO TURN. IT WENT TO MAX WITH NO RESISTANCE. TOOK AN XRAY AND NO CAGE LIFT HAPPENED. HE EXTRACTED THE CAGE EASILY THATS WHEN WE NOTICED THE TIP WAS SHEARED OFF IN THE CAGE. OPENED ANOTHER CAGE, INSERTED AND EXPANDED PERFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597974 ↗
• MalfunctionJun 12, 2018Break; Break

  WE WERE DOING AN L4-5, L3-4 TLIF. OUR STANDARD TECHNIQUE IS TO TRIAL UNTIL WE CANNOT PULL IT OUT USING OPAL TRIALS. WE TRIALED TO 10 AND ALWAYS GO UP ONE ON THE CAGE. SO WE WOULD USE AN 11 OPAL. WE PUT THE EXPANDABLE IN AND EXPANDED HOPING TO TORQUE OUT AT 11MM. IT TORQUED OUT AT THE FIRST LINE. WE COLLAPSED AND PULLED IT OUT. HE DECIDED TO USE AN OPAL AT THIS LEVEL AND USE THE EXPANDABLE AT THE SECOND LEVEL. I HAD THE TECH EXPAND IT TO THE FIRST LINE AND MEASURE IT OUT TO SEE IF IT WAS CLOSE TO 11MM. IT MEASURED 10. THE TECH COLLAPSED IT BACK DOWN. WE WENT TO USE IT ON THE SECOND LEVEL AND THE DRIVER TIP WAS STUCK IN THE END. I FEEL THE TECH BROKE IT OFF WHEN COLLAPSING THE CAGE, BUT DIDN'T TELL ME. I WATCHED IT EXPAND. AS TO WHY IT TORQUED OUT EARLY ON THE FIRST LINE, WE COULD HAVE BEEN RIDING OVER THE TOP OF THE CRUSHED CANCELLOUS AND AUTOGRAFT THAT WE PACK THE DISC SPACE WITH SHORTENING THE DISC HEIGHT. THE HOSPITAL ALSO IS MAKING US USE A MEDTRONIC BONE MILL THAT DOESNT CRUSH THE BONE VERY WELL AND ITS POSSIBLE THE TECH PUT A LARGER PIECE IN THE CAGE TO START AND IT WEDGED THE GEAR ENOUGH TO PREVENT IT FROM OPENING MORE WITHOUT TORQUING. THERE ARE A NUMBER OF VARIABLES GOING O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7592716 ↗