Matrix 04.632.840Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034745800), received between Dec 4, 2018 and Dec 4, 2018 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SPINAL FUSION (L5-S1) SURGERY. DURING THE CONSTRUCT COMPLETION, THE SURGEON NOTICED THAT ONE (1) TITANIUM MATRIX POLYAXIAL SCREW SHAFT ROTATED THEREFORE NO LONGER ACCOMMODATING THE ROD TO FIT INSIDE THE SCREW HEAD. THE SURGEON THEN SIMPLY REMOVED THE SCREW AND CHANGED IT WITH ANOTHER FUNCTIONAL MATRIX SCREW. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 8.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130914 ↗