NA 50-20362Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34546540732027), received between Aug 3, 2018 and Jan 22, 2019 — 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. How this data works · Data updated Oct 13, 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 22, 2019Break

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE THE SCREW BROKE OFF AT THE SHAFT AREA DURING INSERTION. THE BROKEN PIECE WAS REMOVED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8266887 ↗
• MalfunctionAug 3, 2018Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE SURGEON WAS PERFORMING A MANDIBLE INSERT SURGERY, AND ONE OF THE SCREWS BROKE OFF. THE SURGEON OPENED GUM TISSUE TO TRY TO REMOVE THE SCREW SHAFT BUT WAS NOT ABLE TO REMOVE IT. ANOTHER SCREW WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OF SURGERY OVER 30 MINUTES REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7748340 ↗