Matrix 03.632.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034719276), received between Dec 13, 2021 and Sep 21, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 21, 2026Material Integrity Problem

  It was reported that there was a broken driver. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842401 ↗
• MalfunctionOct 5, 2023Compatibility Problem; Manufacturing, Packaging or Shipping Problem; Compatibility Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, DAMAGE WAS NOTED ON THE INSIDE OF THE DETACHABLE RETAINING SLEEVE AND WOULDN¿T ALLOW THE SCREWDRIVER TO PASS THROUGH IT. ALSO, THE DISTRACTOR TIP FOR BONE SCREWS WERE WORN AND NOT FITTING SECURELY. THIS REPORT INVOLVES ONE DETACHABLE HOLDING SLEEVE FOR MATRIX.. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878085 ↗
• MalfunctionDec 13, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SET-UP FOR A PROCEDURE ON (B)(6) 2021, IT WAS NOTED THAT THE SHAFT OF THE FIRST DEVICE WAS BROKEN/SNAPPED OFF, SO IT WAS LEFT ASIDE. A SECOND DEVICE FROM THE SAME KIT WAS INSPECTED TO USE, BUT IT WAS ALSO NOTED THAT THE SPRING ON THE SHAFT WAS COMING OFF. THIS WAS DEEMED UNSAFE TO USE ON PATIENT. THE SAME LIKE DEVICE FROM ANOTHER KIT WAS USED TO PROCEED WITH THE CASE. CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DETACHABLE HOLDING SLEEVE FOR MATRIX. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983832 ↗
• MalfunctionDec 13, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING SET-UP FOR A PROCEDURE ON (B)(6) 2021, IT WAS NOTED THAT THE SHAFT OF THE FIRST DEVICE WAS BROKEN/SNAPPED OFF, SO IT WAS LEFT ASIDE. A SECOND DEVICE FROM THE SAME KIT WAS INSPECTED TO USE, BUT IT WAS ALSO NOTED THAT THE SPRING ON THE SHAFT WAS COMING OFF. THIS WAS DEEMED UNSAFE TO USE ON PATIENT. THE SAME LIKE DEVICE FROM ANOTHER KIT WAS USED TO PROCEED WITH THE CASE. CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DETACHABLE HOLDING SLEEVE FOR MATRIX. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983735 ↗