NA 50-20712Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34546540602597), received between Jun 27, 2018 and May 18, 2020 — classified as 1 injury, 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. 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.

• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING THE PATIENTS POST OPERATIVE CHECK UP, THE PATIENT PRESENTED POSTERIOR OVER BITE ON THE LEFT MANDIBLE AND A NON UNION OF THE LEFT MANDIBLE. THERE WAS A REVISION SURGERY PERFORMED TO REMOVE AND REPLACE THE HARDWARE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10065217 ↗
• MalfunctionJun 27, 2018Break

  IT WAS REPORTED THAT THE SURGEON WAS USING THE GUIDES FOR A CHIN IMPLANT AND THE SCREW BROKE OFF BEFORE FULLY TIGHTENING. THE PART OF THE SCREW THAT HAD BEEN INSERTED WAS REMOVED AND THROWN OUT. THERE WAS NO SURGICAL DELAY NOR MEDICAL INTERVENTION REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643457 ↗