Matrix 03.632.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034718743), received between Nov 30, 2020 and Dec 30, 2021 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 30, 2021Compatibility Problem; Compatibility Problem

  IT WAS FURTHER REPORTED THAT PROCEDURE WAS A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). FIVE DAYS AFTER THE PROCEDURE, PATIENT UNDERWENT REVISION SURGERY DUE TO HEMATOMA. THE OPERATION WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118121 ↗
• MalfunctionNov 30, 2020Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MATRIX MIS PROCEDURE, SEVERAL INSTRUMENTS WERE DAMAGED. TWO (2) ROD INTRODUCERS COULD NO LONGER PROPERLY HOLD THE RODS MAKING IT DIFFICULT FOR PATIENT INSERTION. THE SCREWDRIVER SHAFT WAS STRIPPED AT THE DISTAL END TIP. THE ROD PERSUADER COULD NO LONGER HOLD ITS POSITION ONCE ENGAGED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) MATRIX SIMPLE PERSUADER- STANDARD. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923271 ↗