NA 04.633.280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034746449), received between Oct 16, 2019 and Sep 3, 2021 — classified as 4 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. How this data works · Data updated Oct 13, 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.

• InjurySep 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO BROKEN RODS. THE PATIENT HAD BILATERAL BROKEN RODS AND HAD TO HAVE THEM REPLACED. IT WAS FOUND WHEN THE PATIENT CAME TO THE DOCTOR'S OFFICE FOR THE POST-OP FOLLOW UP. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12422948 ↗
• InjurySep 3, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO BROKEN RODS. THE PATIENT HAD BILATERAL BROKEN RODS AND HAD TO HAVE THEM REPLACED. IT WAS FOUND WHEN THE PATIENT CAME TO THE DOCTOR'S OFFICE FOR THE POST-OP FOLLOW UP. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12422945 ↗
• InjuryOct 16, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A POSTERIOR SPINAL FUSION SURGERY WITH THE MATRIX SYSTEM DUE TO A FRACTURED TITANIUM (TI) HARD PRECONTOURED ROD. ORIGINALLY, THE PATIENT HAD A POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE. ON AN UNKNOWN DATE AFTER THE IMPLANT SURGERY, THE PATIENT REPORTED TO THE SURGEON THAT SHE WAS STILL EXPERIENCING PAIN AFTER THE FUSION HAD HEALED. ADDITIONAL IMAGING WAS TAKEN ON AN UNKNOWN DATE AND WAS ASSESSED THAT A (TI) ROD HAD FRACTURED ON BOTH SIDES JUST BELOW THE L5 SCREWS. THE ORIGINAL IMPLANTS WERE REMOVED FROM THE PELVIS AND WAS REVISED TO T10-S1 FUSION. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN PEDICLE SCREWS (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN POLYAXIAL SCREW HEAD (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN TRANSVERSE CONNECTOR (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN LOCKING CAP (PART# /LOT# /QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9198729 ↗
• InjuryOct 16, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF A POSTERIOR SPINAL FUSION SURGERY WITH THE MATRIX SYSTEM DUE TO A FRACTURED TITANIUM (TI) HARD PRECONTOURED ROD. ORIGINALLY, THE PATIENT HAD A POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE. ON AN UNKNOWN DATE AFTER THE IMPLANT SURGERY, THE PATIENT REPORTED TO THE SURGEON THAT SHE WAS STILL EXPERIENCING PAIN AFTER THE FUSION HAD HEALED. ADDITIONAL IMAGING WAS TAKEN ON AN UNKNOWN DATE AND WAS ASSESSED THAT A (TI) ROD HAD FRACTURED ON BOTH SIDES JUST BELOW THE L5 SCREWS. THE ORIGINAL IMPLANTS WERE REMOVED FROM THE PELVIS AND WAS REVISED TO T10-S1 FUSION. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN PEDICLE SCREWS (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN POLYAXIAL SCREW HEAD (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN TRANSVERSE CONNECTOR (PART# /LOT# /QUANTITY: UNKNOWN), UNKNOWN LOCKING CAP (PART# /LOT# /QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 5.5MM TI HARD PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9198725 ↗