Matrix 04.632.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034744964), received between Mar 6, 2019 and May 7, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) USING A MATRIX WITH OPAL CAGES. THE TOP MATRIX SET SCREWS WERE LOOSENED/POPPED OFF AT BILATERAL L3. THE SET SCREWS AND RODS WERE REMOVED BILATERALLY AND REPLACED WITH L3 POLY HEADS BILATERALLY ALONG WITH NEW SET SCREWS AND RODS. THEY ALSO ADDED A TRANSCONNECTOR. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY THROUGH REINSTRUMENTATION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8588968 ↗
• InjuryMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN L3-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) USING A MATRIX WITH OPAL CAGES. THE TOP MATRIX SET SCREWS WERE LOOSENED/POPPED OFF AT BILATERAL L3. THE SET SCREWS AND RODS WERE REMOVED BILATERALLY AND REPLACED WITH L3 POLY HEADS BILATERALLY ALONG WITH NEW SET SCREWS AND RODS. THEY ALSO ADDED A TRANSCONNECTOR. FRAGMENTS WERE GENERATED AND WERE REMOVED EASILY THROUGH REINSTRUMENTATION. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8588965 ↗
• 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 TI MATRIX LOCKING CAP. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8405128 ↗
• 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 TI MATRIX LOCKING CAP. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8405070 ↗
• InjuryMar 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A POSTERIOR LUMBAR FUSION REVISION SURGERY, A MATRIX SCREWDRIVER SHAFT STARDRIVE BROKE IN THE MATRIX LOCKING CAP. THE BROKEN SCREWDRIVER TIP WAS STUCK IN THE LOCKING CAP. THE SCREWDRIVER TIP COULD NOT BE REMOVED, SO THE SURGEON HAD TO CUT THE ROD TO REMOVE THE SCREW. THERE WAS A FORTY-FIVE TO SIXTY (45-60) MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TI MATRIX LOCKING CAP. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS (B)(4) CAPTURES THE INTRA-OP EVENT WHICH INVOLVES THE MATRIX SCREWDRIVER SHAFT STARDRIVE THAT BROKE IN THE MATRIX LOCKING CAP WHILE (B)(4) CAPTURES THE POST-OP EVENT INVOLVING THE ADJACENT LEVEL DISEASE.

  Patient problems: No Code Available

  MAUDE report 8394937 ↗