MESA® Spinal System 801-06540DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857136120), received between Jul 8, 2020 and Sep 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2021Fracture; Material Deformation; Mechanical Jam; Fracture; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT 4 MESA FOUNDATION SCREWS BROKE AND THE INNER COLLETS GOT "STUCK INTO THE ROD" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS RECORD WILL CAPTURE THE THIRD OF FOUR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478048 ↗
• MalfunctionJul 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE INNER COLLET OF A MESA SPINAL SYSTEM FOUNDATION SCREW; SIZE Ø6.5X40 MM AT L2 BROKE INTRA-OPERATIVELY. THE SCREW WAS REPLACED AND SURGERY WAS SUCCESSFULLY COMPLETED AFTER A 5 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10246496 ↗