Matrix 04.639.745Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034749457), received between Sep 2, 2021 and Sep 2, 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 18, 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.

• MalfunctionSep 2, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR SPINAL FUSION, THE MATRIX DRIVER SLEEVE WAS JAMMING WHEN REMOVING THE SCREW WITH TWO OR THREE THREADS STILL THREADED IN THE BONE SCREW HEAD. THE SCREW WAS NOT LOADED STRAIGHT ON THE DRIVER AND WAS ATTEMPTED TO ADVANCE THE SLEEVE EITHER FORWARD OR BACKWARD WITHOUT ANY MOVEMENT. AFTER THE PROCEDURE ENDED, THE BONE SCREW WAS REMOVED FROM THE DRIVER AND AFTER THE THREADS WAS INSPECTED, IT APPEARED STRIPED. THEN THE SURGEON USED A NEW SCREW AND ATTEMPTED TO THREAD THE DRIVER SLEEVE INTO THE BONE SCREW. IT JAMMED APPROXIMATELY 3/4 OF THE WAY THREADED. WHEN THE SURGEON WENT TO REMOVE THE SLEEVE FROM THE BONE SCREW, THE THREADS AGAIN JAMMED WITH APPROXIMATELY 1/4 OF THE THREADS TO GO. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414789 ↗
• MalfunctionSep 2, 2021Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR SPINAL FUSION, THE MATRIX DRIVER SLEEVE WAS JAMMING WHEN REMOVING THE SCREW WITH TWO OR THREE THREADS STILL THREADED IN THE BONE SCREW HEAD. THE SCREW WAS NOT LOADED STRAIGHT ON THE DRIVER AND WAS ATTEMPTED TO ADVANCE THE SLEEVE EITHER FORWARD OR BACKWARD WITHOUT ANY MOVEMENT. AFTER THE PROCEDURE ENDED, THE BONE SCREW WAS REMOVED FROM THE DRIVER AND AFTER THE THREADS WAS INSPECTED, IT APPEARED STRIPED. THEN THE SURGEON USED A NEW SCREW AND ATTEMPTED TO THREAD THE DRIVER SLEEVE INTO THE BONE SCREW. IT JAMMED APPROXIMATELY 3/4 OF THE WAY THREADED. WHEN THE SURGEON WENT TO REMOVE THE SLEEVE FROM THE BONE SCREW, THE THREADS AGAIN JAMMED WITH APPROXIMATELY 1/4 OF THE THREADS TO GO. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414786 ↗