Matrix 04.632.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034744971), received between Jan 30, 2017 and May 25, 2021 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 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) TI MATRIX TOP LOADING POLYAXIAL HEAD. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11881496 ↗
• MalfunctionSep 24, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX BROKE OFF WHILE THE SURGEON WAS PERFORMING A L4-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND USING MATRIX HEADLESS SYSTEM. WHEN THE SURGEON WENT TO ATTACH THE TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD TO THE TITANIUM MATRIX POLYAXIAL SCREW HE HAD DIFFICULTY SEATING THE HEAD. THE SURGEON THEN ASKED FOR AN UNKNOWN MALLET TO IMPACT IT ON. THE SURGEON RETRIEVED THE BROKEN FRAGMENT AND SWITCHED TO A DIFFERENT INSERTER AND WAS ABLE TO POP ON THE HEAD WITHOUT ISSUE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX (PART NUMBER 03.632.037, LOT 6624739, QUANTITY 1), 7.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH (PART NUMBER 04.632.745, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TI MATRIX TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580121 ↗
• InjuryJun 26, 2020Break; Break

  ADDITIONAL EVENT INFORMATION: ADDITIONAL PROCEDURE DETAILS: THE POLYAXIAL HEAD ¿POPPED OFF¿ WITHIN A COUPLE OF DAYS OF THE INITIAL SURGERY. CORY NOTED THAT THE POLYAXIAL HEAD WAS ATTACHED TO THE PEDICLE SCREW INTRAOPERATIVELY. THE SURGEON DID NOT USE A PRE-ASSEMBLED POLYAXIAL SCREW WHICH IS CONSISTENT WITH HIS NORMAL PROCESS. THE SURGEON TYPICALLY CONFIRMS PROPER ACTUATION OF THE HEAD BEFORE DETACHING THE ASSEMBLY TOOL BUT IT WAS UNKNOWN IF HE TRIALED THE SPECIFIC SCREW PROPERLY. THE SURGEON USED THE REAMER WHICH IS ALSO PART OF HIS NORMAL PROCESS. THE SURGEON FINAL TIGHTENED THE INFERIOR LEVEL FIRST AND THEN DISTRACTED. THE SURGEON HAS BEEN USING THIS SYSTEM FOR OVER 5 YEARS.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10200114 ↗
• MalfunctionApr 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE MATRIX POLYAXIAL SCREW DETACHED FROM AN UNKNOWN MATRIX POLYAXIAL HEAD DURING INSERTION. THE SURGEON WAS USING A MATRIX PRE ASSEMBLED SCREWS IN WHICH THE SHAFT AND THE HEAD OF THE SCREW WERE ATTACHED. THE SURGEON ATTEMPTED TO ATTACH ANOTHER POLYAXIAL HEAD AND IT WOULD NOT ATTACH. THE SURGEON ALSO NOTICED THAT THEIR MAY HAVE BEEN AN ISSUE WITH THE SCREW SHAFT HEAD. THE MATRIX POLYAXIAL SCREW WAS EXPLANTED AND A NEW SCREW WAS USED. THERE WAS SURGICAL DELAY OF THREE (3) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9924217 ↗
• MalfunctionOct 29, 2019Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, THE PATIENT UNDERWENT A SPINE REVISION SURGERY DUE TO A TITANIUM (TI) MATRIX TOP LOADING POLYAXIAL HEAD, THAT HAD SEPARATED FROM AN UNKNOWN L5 SCREW. ORIGINALLY, THE PATIENT HAD AN L4-L5 POSTERIOR SPINAL FUSION CASE ON (B)(6) 2019. ONLY THE LOOSEHEAD WAS REMOVED, AND TWO NEW SET SCREWS WERE APPLIED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN POLYAXIAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN LOCKING CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN TRANSVERSE CONNECTOR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI MATRIX TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9250098 ↗
• 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 TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8405314 ↗
• 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 TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8405249 ↗
• InjuryJun 25, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION AT L3-L4 ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED THE MATRIX TOP LOADING POLYAXIAL HEAD AT L3 RIGHT BECAME DETACHED FROM THE SCREW. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE DETACHED POLYAXIAL HEAD AND SCREW WERE REPLACED WITH A PREASSEMBLED MATRIX POLYAXIAL SCREW. THIS REPORT IS FOR ONE (1) MATRIX TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7635921 ↗
• InjuryFeb 14, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD A LUMBAR FUSION AT L4-L5 USING THE MATRIX SYSTEM ON AN UNKNOWN DATE APPROXIMATELY ONE YEAR AGO. PATIENT PRESENTED TO SURGEON COMPLAINING OF POSTOPERATIVE PAIN ON AN UNKNOWN DATE. X-RAY TAKEN ON AN UNKNOWN DATE DETERMINED THAT A MATRIX TOP-LOADING POLYAXIAL HEAD HAD POPPED OFF ONE OF THE MATRIX SCREWS. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2018, AND THE SURGEON REMOVED THE ENTIRE CONSTRUCT ON THE RIGHT-HAND SIDE, AND REPLACED IT WITH ANOTHER MATRIX CONSTRUCT. THERE WAS NO ALLEGATION OF DEFICIENCY AGAINST THE HARDWARE ON THE LEFT SIDE. THERE WAS NO SURGICAL DELAY, NO FRAGMENTS GENERATED, AND THE PATIENT OUTCOME WAS REPORTEDLY GOOD. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: TITANIUM MATRIX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. 1); TITANIUM MATRIX TOP-LOADING POLYAXIAL HEAD, (PART # 04.632.001, LOT # UNKNOWN, QTY.1); TITANIUM MATRIX LOCKING CAP (PART # 04.632.000, LOT # UNKNOWN, QTY.2); CURVED ROD (PART # UNKNOWN, LOT # UNKNOWN, QTY.1). THIS REPORT IS FOR ONE (1) TI MATRIX TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7270875 ↗
• InjuryJun 7, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT SPINE SURGERY, L5-S1, USING THE MATRIX SPINE SYSTEM. IT WAS REPORTED THAT POST OPERATIVELY THE MODULAR HEAD POPPED OFF, DATE AND TEST UNKNOWN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2017 FOR REVISION. IT WAS REPORTED THAT THE SURGEON REPLACED THE MATRIX TOP LOADING POLYAXIAL HEAD AND PLACED THE SAME ROD BACK IN THE PATIENT WITH TWO NEW SET SCREWS. THERE WERE NO ISSUES REPORTED WITH THE ROD OR SET SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND THE PATIENT WAS REPORTED AS STABLE. IT WAS REPORTED THAT THE SURGEON FELT THE POLYAXIAL HEAD MIGHT HAVE BEEN DAMAGED DURING THE INITIAL IMPLANTATION DUE TO THE STEEP ANGLE AND THE NEED FOR SEVERAL ATTEMPTS TO IMPLANT THE DEVICE. THE SURGEON NOTED THAT ONE OF THE LOCKING TABS ON THE POLYAXIAL HEAD WAS NOTICEABLY BENT UPON EXTRACTION. CONCOMITANT DEVICES REPORTED: SCREW (QUANTITY 1), LOCKING CAP (QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIX TOP LOADING POLYAXIAL HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 6619497 ↗
• MalfunctionApr 27, 2017Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE ON (B)(6) 2017 AT L5-S1 LEVELS, WHILE PLACING A TITANIUM MATRIX TOP LOADING POLYAXIAL HEAD ONTO THE SHAFT OF AN UNKNOWN POLYAXIAL SCREW, A SMALL PORTION OF THE HEAD BROKE OFF OF THE IMPLANT. THERE WAS A FIVE (5) MINUTE DELAY IN SURGERY REPORTED WHILE THE FRAGMENT WAS RETRIEVED. THE SURGERY WAS SUCCESSFULLY COMPLETED AND NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. PATIENT STATUS REPORTED AS FINE. CONCOMITANT DEVICES REPORTED: MATRIX POLYAXIAL HEAD PLACEMENT TOOL (PART #: 03.632.037, LOT #: UNKNOWN, QTY. 1), POLYAXIAL SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6526974 ↗
• MalfunctionJan 30, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT INITIAL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE. DURING THE PROCEDURE, PATIENT WAS IMPLANTED AT L5-S1 DISC LEVEL WITH MATRIX PEDICLE SCREWS, RODS, CAPS AND OPAL 10X11X24 TLIF SPACE AT LEFT SIDE. WHEN DISTRACTOR INSTRUMENT WAS FULLY DISTRACTED, SURGEON NOTICED ONE OF THE POST OF THE MATRIX RACK DISTRACTOR INSTRUMENT IN THE L5 DISC LEVEL HAD FRACTURED AT THE TOP. THE SURGEON REMOVED THE DISTRACTOR ON THE LEFT AND THE BROKEN PIECE OF THE DISTRACTOR ALONG THE L5 TUBE. WHILE REMOVING BOTH THREADED RODS, THE RACK DISTRACTOR INSTRUMENT CAME UNATTACHED FROM THE LEFT L5-S1 BONE SCREWS. ALSO, UPON THREADING THE TUBE ONTO THE S1 TULIP HEAD SCREW IMPLANT, THE TULIP HEAD SCREW POPPED OFF BUT DID NOT BREAK. THE TULIP HEAD SCREW WAS NOT ABLE TO BE REPLACED ON THE ROD BECAUSE THE INNER SADDLE ON TOP OF THE SCREW WAS LOCKED IN THE DOWN POSITION. ENTIRE TULIP HEAD SCREW WAS REMOVED AND A NEW TI MATRIX TULIP HEAD SCREW WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. THE RACK FROM OPPOSITE SIDE WAS PLACED DOWN THE RODS AND EXPANDED TO ALLOW FOR TLIF INSERTION. PATIENT WAS CLOSED UP AND DRAIN INSERTED. THERE WAS 8 MINUTES DELAY IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6286577 ↗