Matrix 03.632.123Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034811130), received between Dec 19, 2016 and Mar 6, 2017 — classified as 2 malfunctions.

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.

• MalfunctionMar 6, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT A T-HANDLE T25 STARDRIVE SHAFT WAS STRIPPED AT THE TIP, THE SLEEVE THREADS OF A HOLDING SLEEVE-STANDARD WITH STOP FOR MATRIX WERE STRIPPED, THE TIP OF THE T-PAL TRIAL SPACER HAS BROKEN OFF, THE TIP OF THE T-PAL SPACER APPLICATOR HAS BROKEN OFF, AND THE SLAP HAMMER BROKE INTO (2) PIECES AT THE VERY LOWEST PART OF THE HAMMER. THIS WAS DISCOVERED DURING ROUTINE INSPECTION. THERE IS NO PATIENT OR CASE INVOLVED. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6380795 ↗
• MalfunctionDec 19, 2016Break; Break

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT IT WAS DISCOVERED THAT THE TIPS ARE WORN OUT ON FOUR (4) T-HANDLE T25 STARDRIVE SHAFT SCREWDRIVERS. IN ADDITION, THE THREADS ON THE DISTAL END OF A SCREWDRIVER SLEEVE WERE FOUND TO BE BROKEN. THE BROKEN PIECE REMAINS SOMEWHAT ATTACHED TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6185117 ↗