CONCORDE LIFT 2878-04-101GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034531243), received between Jul 28, 2017 and Aug 4, 2017 — classified as 3 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2017Break; Break

  ONCE THE CAGE WAS PLACED AND CONFIRMED UNDER FLUOROSCOPY, SURGEON PROCEEDED TO EXPAND THE CAGE WITH THE DRIVER SHAFT AND TORQUE LIMITING HANDLE. THE TORQUE LIMITING HANDLE TORQUED OUT ONCE THE CAGE WAS RAISED TO DESIRED HEIGHT. WHEN THE SHAFT/HANDLE COMBO WAS REMOVED FROM INSERTER, SURGEON NOTICED THE DRIVER TIP HAD SHEARED OFF. SURGEON USED A METAL CUTTING MIDAS TIP TO TRY AND RECOVER THE BROKEN FRAGMENT BUT WAS UNSUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6767710 ↗
• MalfunctionAug 1, 2017Break; Break

  SURGEON WAS EXPANDING CAGE WITH DRIVER AND TORQUE HANDLE AND BROKE TIP OF DRIVER OFF IN CAGE. WAS ABLE TO RETRIEVE FRAGMENT WITH SUCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6757630 ↗
• MalfunctionJul 28, 2017Break; Break

  FINAL TIGHTENING WITH TORQUE LIMITING HANDLE. DID NOT GET EXPANSION WANTED. SWITCHED TO STATIC BLACK HANDLE SHAFT BROKE IMMEDIATELY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6751072 ↗