MatrixMANDIBLE 04.503.414.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587020686), received between Mar 21, 2023 and Oct 25, 2023 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionOct 25, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE HEAD OF THE 14MM SCREW IN QUESTION BROKE ON THE LEFT NATIVE MANDIBLE DURING APPLICATION OF A PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ALL FRAGMENTS GENERATED WERE ABLE TO BE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004786 ↗
• InjuryMar 21, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP THE SCREW BROKE HALFWAY DOWN THE LENGTH OF THE THREADS WHILE BEING INSERTED INTO THE BONE. THE BONE WAS PRE-DRILLED WITH THE PROPER DIAMETER DRILL BIT (1.5MM) FULL THICKNESS OF BOTH CORTEX. THE CASE WAS NOT DELAYED BUT WE WERE NOT ABLE TO USE THE PLATE HOLE IN WHICH THE SCREW BROKE SINCE IT WAS EMBEDDED INTO THE BONE. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.0 TI MATRIXMANDIBLE SCREW STPING 14. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16586017 ↗