MatrixMANDIBLE 04.503.740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587022888), received between Jul 22, 2022 and Oct 5, 2022 — classified as 2 injuries.

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 18, 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.

• InjuryOct 5, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15543167 ↗
• InjuryJul 22, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A HARDWARE REMOVAL AND REPLACEMENT OF MILLED PLATED REQUIRED IN OR DUE TO BROKEN HARDWARE WILL MALOCCLUSION TEETH WAS EXPERIENCED FOLLOWING BROKEN MANDIBLE PLATE. PATIENT HAD PREVIOUS MANDIBLE HARDWARE THAT WAS IMPLANTED ON (B)(6) 2020 FOLLOWING COMPOSITE RESECTION. A STOCK PLATE WAS IMPLANTED BY THE SURGEON ON SAID DATE WITH SIX (6) SCREWS (3 ON EITHER SIDE OF OSTEOTOMY). PATIENT'S PLATE HAD BROKEN AT THE ANTERIOR BEND. NO SCREWS HAD PULLED OUT OF THE PLATE OR BONE. A NEW CUSTOM MILLED PLATE WAS IMPLANTED AND REPOSITIONED THE MANDIBLE BACK INTO OCCLUSION FOLLOWING VIRTUAL OCCLUSION BY THE SURGEON. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: MATRIXMANDIBLE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 6); UNK - EXTRACTION INSTRUMENTS: CMF. THIS REPORT IS FOR ONE (1) TI MATRIXMAND 7X23 ANG RECON PL RT 2.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15084737 ↗