Matrix 03.632.083Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034719252), received between Feb 4, 2021 and Jun 7, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 WHEN INSERTING THE MATRIX SCREW WITH DISTRACTOR TIP LOADED THE DISTRACTOR TIP KEPT LOOSENING. UPON INSPECTION OF THE DISTRACTOR TIP IT WAS NOTICED THAT THE THREADS OF THE DISTRACTOR TIP ARE STRIPPED. ANOTHER DISTRACTOR TIP ON THE SET WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484792 ↗
• MalfunctionOct 5, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT IT WAS NOT POSSIBLE TO PASS THE SCREWDRIVER SHAFT THROUGH THE SLEEVE AND UPON EXAMINATION IT WAS IDENTIFIED THAT THERE WAS A PIECE OF METAL ACROSS THE INSIDE OF THE TUBE BLOCKING IT. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 17878080 ↗
• MalfunctionOct 5, 2023Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM 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 DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 17878076 ↗
• MalfunctionDec 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE DISTRACTOR TIP SHEARED OFF. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113611 ↗
• 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 DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE. THIS IS REPORT 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983644 ↗
• MalfunctionFeb 4, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 6.0MM TI MATRIX SCREW WOULD NOT THREAD ON TO MATRIX SCREWDRIVER. TWO (2) DIFFERENT SCREWS WERE TRIED AND NEITHER WOULD NOT ATTACH TO THE SCREWDRIVER. TWO DIFFERENT DRIVER TIPS WERE ALSO USED TO ATTEMPT TO ATTACH TO THE SCREW UNSUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DISTRACTOR TIP FOR MATRIX DETACHABLE HOLDING SLEEVE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279532 ↗