MANTIS Redux 48289735Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540671240), received between Jul 14, 2016 and Jul 14, 2016 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2016Break; Positioning Problem

  IT WAS REPORTED THAT; SALES REP : AFTER THE SETTING UP 4 SCREWS, THE SURGEON SET UP THE CURVED STEM LENGTH 50 MM AND INSERTED THE NUT WITH NUT DRIVER. DURING THE FINAL TIGHTENING WITH A TORQUE WRENCH AND ANTI-TORQUE WRENCH ON THE LEFT L5 LEVEL, THE NUT DID NOT HOLD INTO THE SCREW HEAD. THE SURGEON REMOVED THE NUT AND OBSERVED THAT THE THREADS OF THE SCREW HEAD (TULIP) WERE DAMAGED. THE SURGEON REMOVED THE NUT ON THE LEFT S1 LEVEL, REMOVED THE LEFT UPPER SIDE AND THE LEFT L5 SCREW. THE SURGEON CHANGED THE LEFT L5 SCREW BY INSERTING A NEW SCREW DIA. 7.5 X 40MM REF. , THEN PLACED ANOTHER ROD, THEN 2 NUTS, AND FINAL TIGHTENING WITH A TORQUE WRENCH. DELAY OF 15-20 MINUTES, TIME TO DISASSEMBLE THE LEFT SIDE ASSEMBLY, REPOSITIONING THE SCREW AND REPLACE THE ROD AND LEFT FINAL TIGHTENING."

  Patient problems: No Code Available

  MAUDE report 5796882 ↗