MANTIS Redux 48289305Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327266948), received between Jan 17, 2018 and Jan 25, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 25, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT: ARTHRODESIS PROCEDURE, PATIENT OPERATED. INSTALLATION AND POSITIONING OF THE PATIENT. PREPARING THE PEDICLE SIGHT WITH JAM SHIDI TROCAR . WHEN THE DOCTOR WANTED TO IMPLANT THE SCREW THROUGH THE PEDICLE WITH THE SCREWDRIVER, THE HANDLE BROKE AT THE RACK. HE HAD TO USE ANOTHER HANDLE TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF ABOUT 5-10 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7220397 ↗
• MalfunctionJan 17, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; OR MANAGER AT THE CLINIC, REPORTED THE FOLLOWING EVENT TO , SALES REP : "ARTHRODESIS PROCEDURE, PATIENT OPERATED BY DOCTOR. INSTALLATION AND POSITIONING OF THE PATIENT WAS PERFORMED. WHILE PREPARING THE PEDICLE SIGHT WITH JAM SHIDI TROCAR, HE WANTED TO IMPLANT THE SCREW THROUGH THE PEDICLE WITH THE SCREWDRIVER, THE HANDLE BROKE AT THE RACK. HE HAD TO USE ANOTHER HANDLE TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF ABOUT 5-10 MINUTES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199459 ↗