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Matrix 04.634.002Recalls & reported problems

Synthes GmbH · TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034747507), received between Oct 26, 2020 and Oct 26, 2020 — classified as 2 malfunctions.

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

Most reported problems

Device problems

  • Break2
  • Material Integrity Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 26, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SPINE PROCEDURE THE TITANIUM POLYAXIAL 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) TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

    MAUDE report 10734031 ↗
  • MalfunctionOct 26, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

    IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SPINE PROCEDURE THE TITANIUM POLYAXIAL 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) TI POLYAXIAL REDUCTION HEAD FOR TI MATRIX SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

    MAUDE report 10733972 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.