Matrix 04.639.650Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034749327), received between Oct 26, 2020 and Apr 21, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 18, 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.

• InjuryApr 21, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT THE SURGERY ON (B)(6), 2020 FOR L4-L5-S1 ARTHRODESIS. SINCE THEN PATIENT HAD SUFFERED A BREAKAGE OF SCREWS AND VERTEBRAL MATRIX FIXATOR, WITH PROBLEMS AND SEQUELAE CAUSED AFTER L4-L5-S1 ARTHRODESIS, WITH TORSION BREAKAGE AND SUSPENSION BARS AND IMPRINT, WITH NEED OF SURGICAL RE-INTERVENTION, REMOVAL OF FIXATOR AND REARRIDESIS 360. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11702064 ↗
• MalfunctionFeb 4, 2021Compatibility Problem; Compatibility Problem

  UPDATED EVENT DESCRIPTION: THE T25 DRIVER TIP WAS THE ITEM USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279792 ↗
• MalfunctionFeb 3, 2021Compatibility Problem; Compatibility Problem

  UPDATED EVENT DESCRIPTION: THE T25 DRIVER TIP WAS THE ITEM USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276142 ↗
• MalfunctionOct 26, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SPINE PROCEDURE THE TITANIUM POLY AXIAL HEAD FOR TITANIUM MATRIX SCREWS CAME OFF OR WERE NOT APPLIED CORRECTLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10734002 ↗