NA 03.503.034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587011608), received between Dec 10, 2019 and Oct 21, 2022 — 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.

• MalfunctionOct 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS IDENTIFIED BY THE MDR STAFF AND NURSES THAT THE FOLLOWING INSTRUMENTS FROM THE MATRIX MANDIBLE SET NEED REPLACEMENT DUE TO WEAR AND TEAR AND OR BREAKAGE: ITEM 03.503.034, THE TIP OF THE PLATE HOLDER WAS BROKEN. NO PATIENT INVOLVEMENT. ITEM 03.503.038, THE SPRING MECHANISM OF THE BENDER IS NO LONGER FUNCTIONAL, THEREFORE CAN'T PROPERLY USE THE FORCEPS TO BEND THE PLATES. ITEM 03.503.043, THE COLOR CODED RING ON THE DRILL GUIDE IS ALL WORN OFF AND NUMBERS ON THE TOP OF THE DRILL GUIDE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MINI PLATE HOLDER LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650987 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, A PLATE HOLDER LONG WAS FOUND WITH A BROKEN TIP AT CENTRAL STERILE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444403 ↗