MANTIS 48281161Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327266504), received between Mar 11, 2016 and Jul 18, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• MalfunctionJul 18, 2017Fracture; Difficult to Insert

  IT WAS REPORTED THAT; TREATMENT FOR L2 FRACTURE. THE L1 LEFT VERTEBRAL BONE WAS HARD AND COULD NOT INSERT THE TAP COMPLETELY INTO L1. BUT INSERTED THE SCREW AND COMPLETE THE PROCEDURE. AFTER THAT IT WAS FOUND THE TIP OF TAP WAS FRACTURED AFTER PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722985 ↗
• MalfunctionMar 21, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS PREPARING A PEDICLE TO IMPLANT A SCREW WHEN THE TIP OF THE TAP BROKE. THE PATIENT HAD EXTREMELY HARD BONE AT THIS LEVEL. THE SURGEON TRIED TO USE A LARGER TAP BUT THE BROKEN FRAGMENT WAS IN THE PEDICLE WHICH PREVENTED FROM IMPLANTING A SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514620 ↗
• MalfunctionMar 11, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE SURGEON WAS USING A TAP, THE SURGEON FOUND THAT THE TIP OF THE TAP BROKE. THEREFORE THE SURGEON REMOVED THE BROKEN TIP OF THE TAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5495969 ↗