MatrixMANDIBLE 03.503.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587011776), received between Jan 23, 2017 and Jul 30, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE BENDING PLIERS DIDN¿T BEND ALL THE WAY; THEREFORE, THE PLATES COULD NOT BE BENT TO SATISFACTION. THE SURGEON BENT THE PLATES WITH HIS HANDS AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PATIENT OR SURGICAL DELAY. THIS REPORT IS FOR BENDING PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19863824 ↗
• MalfunctionMar 15, 2017Break; Break

  IT WAS REPORTED THAT WHILE REFILLING AND ASSEMBLING A MATRIX MANDIBLE SET, IT WAS NOTICED THE SPOT WELDED SCREW IN THE MATRIX MANDIBLE COMBINATION BENDER HAD BROKEN AND THE SCREW WAS BACKING OUT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6408369 ↗
• MalfunctionJan 23, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PLATE BENDER FELL APART DURING A SURGERY TO TREAT A MANDIBLE FRACTURE ON (B)(6) 2017. THE SURGEON WAS GOING TO BEND THE LAST HOLE ON THE MANDIBLE PLATE WHEN THE PLATE BENDER FELL APART. ALL PIECES WERE RETRIEVED WITH NO ADDITIONAL MEDICAL INTERVENTION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED AS VERY GOOD. CONCOMITANT MEDICAL PRODUCTS: MANDIBLE PLATE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6270725 ↗