Matrix 04.639.645Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034749310), received between Mar 8, 2019 and May 25, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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.

• InjuryMay 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, APPARENT DISLODGING OBSERVED IN POST-OP FILMS. IN REVIEWING A POST-OP X-RAY, THE DOCTOR OBSERVED THAT ONE OF THE MATRIX POLYAXIAL HEADS MAY HAVE DISLODGED FROM THE MATRIX BONE SCREW AT L3. THERE WERE NO OBVIOUS ISSUES WITH IMPLANTS OR INSTRUMENTATION INTRA-OPERATIVELY AND THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE GUIDELINES TO VERIFY THE IMPLANT PLACEMENT PRIOR TO FINAL TIGHTENING. IMPLANTS WERE PLACED ON (B)(6) 2021. UNKNOWN IF FUTURE REVISION WILL BE REQUIRED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11881564 ↗
• InjuryApr 21, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT INITIALLY UNDERWENT THE SURGERY ON (B)(6) 2020 FOR L4-L5-S1 ARTHRODESIS. SINCE THEN PATIENT HAD SUFFERED A BREAKAGE OF SCREWS AND VERTEBRAL MATRIX FIXATOR, WITH PROBLEMS AND SEQUELAE CAUSED AFTER L4-L5-S1 ARTHRODESIS, WITH TORSION BREAKAGE AND SUSPENSION BARS AND IMPRINT, WITH NEED OF SURGICAL RE-INTERVENTION, REMOVAL OF FIXATOR AND REARRIDESIS 360. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 11702062 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION REVISION SURGERY TO EXTEND THE CONSTRUCT 1 LEVEL UP FOR ADJACENT LEVEL DISEASE AT L4-L5. THE CONSTRUCT WAS S1-L5 AND WAS EXTENDED UP TO L4-S1. TWO (2) 6.0MM TITANIUM MATRIX SCREW, TWO (2) 5.5MM TITANIUM CURVED ROD, TWO (2) TITANIUM MATRIX LOCKING CAP, AND TWO (2) TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD WERE THE DEVICES IMPLANTED AT L4, THE SITE OF THE ADJACENT LEVEL DISEASE AT L4-L5. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8404911 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION REVISION SURGERY TO EXTEND THE CONSTRUCT 1 LEVEL UP FOR ADJACENT LEVEL DISEASE AT L4-L5. THE CONSTRUCT WAS S1-L5 AND WAS EXTENDED UP TO L4-S1. TWO (2) 6.0MM TITANIUM MATRIX SCREW, TWO (2) 5.5MM TITANIUM CURVED ROD, TWO (2) TITANIUM MATRIX LOCKING CAP, AND TWO (2) TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD WERE THE DEVICES IMPLANTED AT L4, THE SITE OF THE ADJACENT LEVEL DISEASE AT L4-L5. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8404829 ↗