Matrix 04.632.645Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034745534), received between May 26, 2017 and Feb 13, 2024 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENTS RIGHT IMPLANT WAS RUPTURED. THE REVISION SURGERY TOOK PLACE AND BOTH IMPLANTS WERE REMOVED. THE NEW IMPLANTS WERE PLACED WITH A FUNNEL IN THE SAME SUBMUSCULAR PLANE. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX POLYAX SCRW 45MM TH L. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699420 ↗
• InjuryFeb 13, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENTS RIGHT IMPLANT WAS RUPTURED. THE REVISION SURGERY TOOK PLACE AND BOTH IMPLANTS WERE REMOVED. THE NEW IMPLANTS WERE PLACED WITH A FUNNEL IN THE SAME SUBMUSCULAR PLANE. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX POLYAX SCRW 45MM TH L. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699414 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A CONCORD LIFT IMPLANT COLLAPSING. IT WAS NOTED THAT TWO (2) MATRIX POLYAXIAL SCREWS WERE ALSO BROKEN AND THOUGHT TO BE CAUSED BY THE COLLAPSING CAGE. ALL FOUR (4) OF THE PREVIOUS MATRIX SCREWS WERE REMOVED AND REPLACED WITH FOUR (4) MATRIX SCREW 7X45. THE PRIMARY CAUSE OF THE NEED FOR REVISION SURGERY WAS DUE TO THE CONCORD LIFT COLLAPSING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: MATRIX POLYAXIAL SCREWS (PART# 04.632.645, LOT# UNKNOWN, QTY 3); LOCKING CAPS (PART# UNKNOWN LOT# UNKNOWN, QTY 4), ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY 2), CONCORD LIFT (PART # 197809023L, LOT # UNKNOWN, QUANTITY 1) THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9795334 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A CONCORD LIFT IMPLANT COLLAPSING. IT WAS NOTED THAT TWO (2) MATRIX POLYAXIAL SCREWS WERE ALSO BROKEN AND THOUGHT TO BE CAUSED BY THE COLLAPSING CAGE. ALL FOUR (4) OF THE PREVIOUS MATRIX SCREWS WERE REMOVED AND REPLACED WITH FOUR (4) MATRIX SCREW 7 X 45. THE PRIMARY CAUSE OF THE NEED FOR REVISION SURGERY WAS DUE TO THE CONCORD LIFT COLLAPSING. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: MATRIX POLYAXIAL SCREWS (PART # 04.632.645, LOT # UNKNOWN, QTY 3); LOCKING CAPS (PART # UNKNOWN LOT # UNKNOWN, QTY 4), ROD (PART # UNKNOWN, LOT # UNKNOWN, QTY 2), CONCORD LIFT (PART # 197809023L, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9795321 ↗
• MalfunctionMay 26, 2017Unintended Movement; Unintended Movement

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HEAD OF A POLYAXIAL PEDICLE SCREW LOOSENED WHILE INSERTING DURING SURGERY ON (B)(6) 2017. THE SCREW WAS EXCHANGED INTRA-OPERATIVELY; THERE WAS A THREE (3) MINUTE SURGICAL DELAY, BUT NO PATIENT HARM WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6594171 ↗