MATRIXWAVE 04.503.824.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587069470), received between Apr 22, 2019 and Oct 5, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 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.

• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE SURGEON STATED THAT A MATRIX WAVE SCREW DAMAGED THE ROOT OF A TOOTH. THE PATIENT LOST THE TOOTH AFTER THE ROOT WAS PIERCED BY THE MATRIX WAVE SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nerve Damage; Unspecified Tissue Injury

  MAUDE report 15542255 ↗
• MalfunctionMay 12, 2022Failure to Cut; Failure to Cut

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ORTHOGNATHIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO MATRIXWAVE F TI 1.85 SCR SELF-DRL/6 LNTH DEVICES WERE BLUNT AND UNABLE TO SELF-DRILLING. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377011 ↗
• MalfunctionMay 12, 2022Failure to Cut; Failure to Cut

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ORTHOGNATHIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO MATRIXWAVE F TI 1.85 SCR SELF-DRL/6 LNTH DEVICES WERE BLUNT AND UNABLE TO SELF-DRILLING. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376809 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE MANDIBLE FRACTURE, THE MATRIXWAVE TITANIUM SCREW SELF-DRILLING WAS INSERTED FOR TEMPORARY FIXATION AND AS THE SURGEON WAS BACKING OUT THE SCREW IT BROKE IN HALF MIDWAY UP THE SHAFT. FRAGMENTS WERE GENERATED BUT IT WAS NOT REMOVED EASILY. THE BROKEN SCREW SHAFT WAS VIRTUALLY FLUSH WITH BONE AND WAS LEFT IN THE PATIENT'S BONE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIXWAVE MMF TI 1.85MM SCREW SELF-DRILLING/6MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8536461 ↗