Matrix 04.632.880Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034745886), received between Feb 14, 2017 and Feb 14, 2017 — classified as 2 injuries.

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. 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.

• InjuryFeb 14, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A NONUNION AND BROKEN SCREWS. PATIENT WAS INITIALLY IMPLANTED WITH DEPUY¿S RODS FROM T10-S2, DEPUY¿S SCREWS FROM T10-L5, AND SYNTHES¿ SCREWS AT S2 ON (B)(6) 2015 DUE TO DISC DEGENERATION AND SCOLIOSIS. NO SCREWS WERE IMPLANTED AT S1. X-RAYS TAKEN DURING A ROUTINE FOLLOW UP ON UNKNOWN DATE REVEALED THAT THE L5 RIGHT AND S2 RIGHT PEDICLE SCREWS WERE BROKEN. PATIENT ALSO HAD LEG PAIN THAT SURGEON ASSOCIATED WITH ARTHRITIS. SURGEON CONTINUED TO KEEP SURVEILLANCE ON THE SITUATION AND MONITOR THE PATIENT WITH CHECKUPS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. PATIENT WAS SYMPTOMATIC AT T8-T9, HAD CORD COMPRESSION AT T8-T9, AND EXPERIENCED A NONUNION DUE TO THE BROKEN SCREWS. DURING THE REVISION SURGERY, IT WAS FOUND THAT THREE SCREWS BROKE. TWO SYNTHES¿ 8.0 MM MATRIX POLYAXIAL SCREWS BROKE AT S2 AND ONE DEPUY¿S SCREW BROKE AT THE RIGHT SIDE AT L5. NO FRAGMENTS WERE GENERATED FROM THE BROKEN SCREWS AND THEY WERE EASILY REMOVED. SURGEON ALSO REMOVED THE ROD TO PERFORM A COSTOTRANSVERSECTOMY AT T8-T9. IN ADDITION, A LAMINECTOMY WAS PERFORMED AT L5-S1. NO MEDICAL INTERVENTION REQUIRED. REVISION SURGERY WAS SUCCESSFULLY COMP

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6330319 ↗
• InjuryFeb 14, 2017Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A NONUNION AND BROKEN SCREWS. PATIENT WAS INITIALLY IMPLANTED WITH DEPUY¿S RODS FROM T10-S2, DEPUY¿S SCREWS FROM T10-L5, AND SYNTHES¿ SCREWS AT S2 ON (B)(6) 2015 DUE TO DISC DEGENERATION AND SCOLIOSIS. NO SCREWS WERE IMPLANTED AT S1. X-RAYS TAKEN DURING A ROUTINE FOLLOW UP ON UNKNOWN DATE REVEALED THAT THE L5 RIGHT AND S2 RIGHT PEDICLE SCREWS WERE BROKEN. PATIENT ALSO HAD LEG PAIN THAT SURGEON ASSOCIATED WITH ARTHRITIS. SURGEON CONTINUED TO KEEP SURVEILLANCE ON THE SITUATION AND MONITOR THE PATIENT WITH CHECKUPS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. PATIENT WAS SYMPTOMATIC AT T8-T9, HAD CORD COMPRESSION AT T8-T9, AND EXPERIENCED A NONUNION DUE TO THE BROKEN SCREWS. DURING THE REVISION SURGERY, IT WAS FOUND THAT THREE SCREWS BROKE. TWO SYNTHES¿ 8.0 MM MATRIX POLYAXIAL SCREWS BROKE AT S2 AND ONE DEPUY¿S SCREW BROKE AT THE RIGHT SIDE AT L5. NO FRAGMENTS WERE GENERATED FROM THE BROKEN SCREWS AND THEY WERE EASILY REMOVED. SURGEON ALSO REMOVED THE ROD TO PERFORM A COSTOTRANSVERSECTOMY AT T8-T9. IN ADDITION, A LAMINECTOMY WAS PERFORMED AT L5-S1. NO MEDICAL INTERVENTION REQUIRED. REVISION SURGERY WAS SUCCESSFULLY COMP

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6330281 ↗