MANTIS 48480111Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327270815), received between Jun 21, 2016 and Nov 25, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL TIP DISENGAGED INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9372925 ↗
• MalfunctionApr 17, 2017Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Device Inoperable; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT DURING MEDICAL PROCEDURE THE ROD INSERTER WAS WITHOUT FUNCTION. THE DISTAL END OF THE ITEM LOOSENED FROM THE RESIDUE OF THE INSTRUMENT. A PROPER FIXATION OF THE ROD WAS NOT POSSIBLE ANYMORE. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498965 ↗
• MalfunctionApr 13, 2017Detachment Of Device Component; Loose or Intermittent Connection; Mechanical Problem; Device Operates Differently Than Expected; Detachment Of Device Component; Mechanical Problem

  IT WAS REPORTED THAT DURING MEDICAL PROCEDURE THE ROD INSERTER WAS WITHOUT FUNCTION. THE DISTAL END OF THE ITEM LOOSENED FROM THE RESIDUE OF THE INSTRUMENT. A PROPER FIXATION OF THE ROD WAS NOT POSSIBLE ANYMORE. REPLACEMENT WAS AVAILABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490353 ↗
• InjuryOct 27, 2016Material Erosion; Difficult to Remove

  IT WAS REPORTED THAT; WHEN TRYING TO REMOVE THE INSERTER FROM THE ALREADY FINAL FIXED IMPLANTATION CONSTRUCT, THE LOWER PART OF THE INSERTER DISSOLVED. THE CUT WAS EXTENDED BY 1CM AND THE INSTRUMENT COULD BE REMOVED COMPLETELY. REPLACEMENT WAS AVAILABLE AND THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. SALES REP WAS PRESENT DURING SURGERY.

  Patient problems: No Information

  MAUDE report 6060460 ↗
• MalfunctionJun 21, 2016Loose or Intermittent Connection; Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT; TIP OF ROD INSERTER CAME LOOSE DURING ROD INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5740188 ↗