MATRIXWAVE 04.503.820Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587069432), received between Dec 26, 2017 and Feb 23, 2021 — 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.

• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 MATRIX WAVE PLATE BROKE IN 2 PIECES, WHILE BEING INSERTED. THE MATRIX WAVE PLATE WAS THEN REPLACED BY ARCH BARS. THE SURGERY WAS DELAYED FOR 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS COMPLAINT IS FOR ONE (1) MATRIXWAVE MMF TI PLATE 10 HOLES/SHORT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365660 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REPAIR AN ANGULAR MANDIBLE FRACTURE ON (B)(6) 2015. THE FRACTURE WAS FRACTURE WAS NON-DISCPLACED AND TREATED STRICTLY WITH MANDIBULO-MAXILLARY FIXATION. THE PATIENT HAD ATTEMPTED TO REMOVE THEIR OWN MOLAR. POSTOPERATIVELY, ON (B)(6) 2015, IT WAS IDENTIFIED THAT THE PATIENT HAD PRESENTED WITH NON-UNION OF THE FRACTURE SITE AND AN INFECTION NOT NEAR THE CONSTRUCT. THE UNKNOWN INFECTION WAS TREATED WITH MULTIPLE COURSES OF ANTIBIOTICS AND THE THE INFECTED AREA WAS DEBRIDED AND FIXED WITH A BICORTICAL RECON BAR. ON (B)(6) 2015, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE SURGEON REMOVED TWO SYNTHES MATRIXWAVE MAXILLOMANDIBULAR FIXATION (MMF), AND 12 UNKNOWN 6MM SCREWS. THE FRACTURE WAS NOTED TO HAVE FULLY HEALED AT THAT TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7146270 ↗