MatrixMANDIBLE 03.503.911Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587013268), received between Jun 8, 2022 and Jun 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJun 8, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THERE WERE 2 MATRIXMANDIBLE TEMPLATES THAT WOULD NOT FUNCTION. SPECIFIC MALFUNCTION WAS NOT REPORTED. IT WAS UNKNOWN WHEN THE DEVICES MALFUNCTIONED. THERE IS NO KNOWN PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR A MATRIXMANDIBLE BNDNG TEMPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633397 ↗
• MalfunctionJun 8, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THERE WERE 2 MATRIXMANDIBLE TEMPLATES THAT WOULD NOT FUNCTION. SPECIFIC MALFUNCTION WAS NOT REPORTED. IT WAS UNKNOWN WHEN THE DEVICES MALFUNCTIONED. THERE IS NO KNOWN PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR A MATRIXMANDIBLE BNDNG TEMPLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633202 ↗