Matrix 03.632.087Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034719290), received between Jan 30, 2017 and Oct 1, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , WHEN THE SURGEON WAS USING THE RETRACTOR THE SCREW WITHIN THE 2 PART TOOTHED DISTRACTOR WOULD NOT TIGHTEN COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT INVOLVES ONE TOOTHED RACK RETRACTOR F/MATRIX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345577 ↗
• MalfunctionOct 5, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE MATRIX DISTRACTOR KEEPS SLIPPING AND WILL NOT LOCK IN PLACE. THE SURGEON COULD NOT KEEP THE SCREWS DISTRACTED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MATRIX DISTRACTOR RACK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875892 ↗
• MalfunctionMay 19, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT IN THE STERILIZATION DEPARTMENT IT WAS FOUND THAT A SPRING HAD BROKEN OFF AND THE SPREADER WAS THEREFORE BROKEN. THE SURGERY AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MATRIX DISTRACTOR RACK. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850324 ↗
• MalfunctionJan 30, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT INITIAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. DURING THE PROCEDURE, PATIENT WAS IMPLANTED AT L5-S1 DISC LEVEL WITH MATRIX PEDICLE SCREWS, RODS, CAPS AND OPAL 10X11X24 TLIF SPACE AT LEFT SIDE. WHEN DISTRACTOR INSTRUMENT WAS FULLY DISTRACTED, SURGEON NOTICED ONE OF THE POSTS OF THE MATRIX RACK DISTRACTOR INSTRUMENT IN THE L5 DISC LEVEL HAD FRACTURED AT THE TOP. THE SURGEON REMOVED THE DISTRACTOR ON THE LEFT AND THE BROKEN PIECE OF THE DISTRACTOR ALONG THE L5 TUBE. WHILE REMOVING BOTH THREADED RODS, THE RACK DISTRACTOR INSTRUMENT CAME UNATTACHED FROM THE LEFT L5-S1 BONE SCREWS. ALSO, UPON THREADING THE TUBE ONTO THE S1 TULIP HEAD SCREW IMPLANT, THE TULIP HEAD SCREW POPPED OFF BUT DID NOT BREAK. THE TULIP HEAD SCREW WAS NOT ABLE TO BE REPLACED ON THE ROD BECAUSE THE INNER SADDLE ON TOP OF THE SCREW WAS LOCKED IN THE DOWN POSITION. ENTIRE TULIP HEAD SCREW WAS REMOVED AND A NEW TI MATRIX TULIP HEAD SCREW WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. THE RACK FROM OPPOSITE SIDE WAS PLACED DOWN THE RODS AND EXPANDED TO ALLOW FOR TLIF INSERTION. PATIENT WAS CLOSED UP AND DRAIN INSERTED. THERE WAS EIGHT (8) MINUTES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6286580 ↗