MANTIS Redux 48289745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540671264), received between Apr 11, 2017 and Apr 11, 2017 — 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.

• MalfunctionApr 11, 2017Break; Crack; Fracture; Defective Component; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT : "MOUNTING L5-S1, INSERTING SCREWS*, PEDICULAR SIGHT WITH SQUARE POINT, PEDICLE PROBE, PALPATOR. INSERT THE SCREW WITH THE REDUX SCREWDRIVER. INSTALLATION OF THE ROD AND NUT. WHEN INSERTING THE NUT INTO THE L5 SCREW HEAD THEN INSERTING THE NUT INTO THE SCREW HEAD IN S1. ON THE LEFT SIDE, WHEN THE NUT IS INSERTED INTO THE SCREW HEAD IN S1, THE SCREW THREAD HAS "FOULED". THE SURGEON TRIED TO CHANGE THE NUT AND INSERT THE NEW NUT INTO THE SCREW HEAD. BY BREAKING THE FINS IN S1, THE SURGEON NOTICED THAT THE NUT WAS NOT HOLDING; THE SCREW THREAD HAS "CRACKED" UNDER THE REDUCTION THREAD. THE SURGEON THEREFORE REMOVED THE NUT IN L5, THEN THE STEM TO REPLACE THE SCREW IN S1. * DURING THE L5 PEDICLE SIGHTING, THE INSTRUMENTALIST HAS MOUNTED THE SCREW ON THE REDUX SCREWDRIVER, THE ARMS, REDUX VIS DIA. 7.5 X 45MM, STERILE: 1 UNIT. CONSEQUENTLY, THE INSTRUMENTALIST USED A NEW REDUX SCREW, SURGICAL DELAY OF 30 MIN".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6483150 ↗