MATRIXWAVE 04.503.825.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587069487), received between May 30, 2018 and Sep 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE DOING A MANDIBLE CASE, AN 8MM MATRIX WAVE SCREW BROKE OFF IN THE PATIENT¿S MANDIBLE AND WAS RETAINED. THE SURGERY WAS COMPETED SUCCESSFULLY. THE MANDIBLE WAS PLATED, AND THE PATIENT WILL FOLLOW UP IN THE CLINIC. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17699055 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SCREW BROKE OFF IN THE PATIENTS MANDIBLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) MATRIXWAVE F TI 1.85 SCR SELF-DRL/8 LNTH. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712850 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SCREW BROKE OFF IN THE PATIENTS MANDIBLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) MATRIXWAVE F TI 1.85 SCR SELF-DRL/8 LNTH. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712847 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON PERFORMED AN UNKNOWN PROCEDURE AND THE MATRIX WAVE SCREW BROKE OFF DURING IMPLANTATION. THE BROKEN SHAFT OF THE SCREW WAS REMOVED. THERE WAS A SURGICAL DELAY OF 15 MINUTES. IT WAS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. NO PROCEDURE OUTCOME REPORTED. THIS REPORT IS FOR A MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/8MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7553680 ↗