MatrixMANDIBLE 03.505.075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587013619), received between Jun 26, 2018 and May 1, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SSRO FOR JAW DEFORMITY PERFORMED ON (B)(6) 2023. DRILLING WAS PERFORMED ON THE MANDIBLE; HOWEVER, IT COULD NOT BE DRILLED. ALTHOUGH THE DRILL BIT WAS CHANGED TO DIFFERENT DRILL BITS, THE SAME RESULT WAS OBTAINED. THE SHAFT WAS CHANGED, AND DRILLING WAS DONE SUCCESSFULLY. PER THE SURGEON, THE DRILL BITS STOPPED DURING DRILLING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.5 W/STOP L13/6 2FLUTE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845310 ↗
• MalfunctionMay 23, 2019Break; Break

  CONCOMITANT DEVICE REPORTED: UNKNOWN ELAN HANDPIECE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: Not Applicable

  MAUDE report 8637509 ↗
• InjuryJun 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TIPS OF TWO (2) MATRIXMANDIBLE DRILL BITS BROKE WHILE DRILLING THE HOLE. THE TIPS COULD NOT BE RECOVERED AND WERE LEFT INSIDE THE PATIENT¿S BONE. THERE WAS NO PATIENT CONSEQUENCE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7638678 ↗
• InjuryJun 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TIPS OF TWO (2) MATRIXMANDIBLE DRILL BITS BROKE WHILE DRILLING THE HOLE. THE TIPS COULD NOT BE RECOVERED AND WERE LEFT INSIDE THE PATIENT¿S BONE. THERE WAS NO PATIENT CONSEQUENCE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7638674 ↗