Matrix 03.632.037Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034718958), received between Dec 30, 2016 and Mar 24, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN INSPECTING THE INSTRUMENTS POST-OPERATIVELY, IT WAS NOTICED THAT THE END OF THE POLY HEAD INSERTER FROM MATRIX HAD DETACHED FROM THE END, RENDERING THE INSTRUMENT REDUNDANT. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610089 ↗
• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, MATRIX POSITIONING INSTRUMENTS WERE BROKEN DURING SURGERY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555293 ↗
• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, MATRIX POSITIONING INSTRUMENTS WERE BROKEN DURING SURGERY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555279 ↗
• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, MATRIX POSITIONING INSTRUMENTS WERE BROKEN DURING SURGERY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555272 ↗
• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, MATRIX POSITIONING INSTRUMENTS WERE BROKEN DURING SURGERY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555263 ↗
• MalfunctionJul 6, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR INSTRUMENTED FUSION CASE THE SURGEON NOTED THAT A SMALL SECTION OF THE TIP OF THE MATRIX HEAD POSITIONER WAS BROKEN OFF. THE BROKEN PART WAS REMOVED WITH NO FRAGMENT LEFT BEHIND. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYS AS THERE ARE TWO INSTRUMENTS ON THE MATRIX TRAY. CONCOMITANT DEVICE REPORTED: UNKNOWN POLYAXIAL SCREW HEADS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12123123 ↗
• MalfunctionSep 24, 2020Break; Break

  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), TI MATRIX TOP LOADING POLYAXIAL HEAD (PART 04.632.001, LOT UNKNOWN, 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) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580053 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE POLYXIAL HEAD PLACEMENT TOOL FOR MATRIX HAD A DAMAGED END PIECE WHEN PUTTING THE KIT BACK TOGETHER. THE DAMAGE WAS NOTICED WHEN THE INSTRUMENT WAS BEING THREADING BACK TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE RECEIVED DEVICE WAS BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THAT THE HEAD PLACEMENT TOOL WAS MISSING THE BLOCKER COMPONENT, WHICH IS WELDED TO THE OUTER SHAFT COMPONENT. THE WELD WAS THEREFORE BROKEN. THIS REPORT IS FOR A POLYXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8240418 ↗
• MalfunctionOct 8, 2018Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON OPENING THE TRAY, THE NURSING STAFF NOTICED THAT THE POLYAXIAL SCREW HEAD INSTRUMENT CLIP AT THE END OF THE INSTRUMENT WAS BROKEN OFF. THEREFORE, THE POLYAXIAL HEADS OF THE INSTRUMENT WOULD NOT LOAD. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT REPORTED. THIS REPORT IS FOR A POLYAXIAL HEAD PLACEMENT TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7942542 ↗
• MalfunctionJul 27, 2018Break; Break

  IT WAS REPORTED THAT DURING A FIELD INVENTORY INSPECTION ON (B)(6) 2018, A POLYAXIAL HEAD PLACEMENT TOOL WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7728909 ↗
• MalfunctionApr 30, 2018Break; Break

  IT WAS REPORTED THAT DURING SETUP FOR A PROCEDURE THE SCRUB TECH DISCOVERED THAT THE MATRIX HEAD APPLICATION TOOL WAS BROKEN. THE INTERNAL PIECE ON THE DISTAL WORKING END HAD SOMEHOW SNAPPED OFF AND WAS ROLLING AROUND IN THE TRAY. FORTUNATELY, ANOTHER INSTRUMENT WAS AVAILABLE AND WAS USED IN THE PROCEDURE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT, THE MALFUNCTION WAS DISCOVERED PRIOR TO THE PROCEDURE BEGINNING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7474011 ↗
• MalfunctionApr 9, 2018Break; Break

  IT WAS REPORTED THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX WAS NOTED TO BE BROKEN. ISSUE WAS DISCOVERED IN STERILE PROCESSING WHILE PUTTING SETS TOGETHER. ONE (1) PIECE THAT BROKE OFF IS MISSING, THE MAIN PIECE IS AVAILABLE. NO PATIENT OR SURGICAL PROCEDURE INVOLVED. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7409763 ↗
• MalfunctionApr 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BUTTON OF THE POSITION-INSTR F/POLYAXIAL SCREW HEADS WAS NOT FUNCTIONING PROPERLY. THE ISSUE WAS FOUND DURING AN INSPECTION OF THE SET AT THE LOANER DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7397135 ↗
• MalfunctionJan 20, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT WAS BEING IMPLANTED FROM T11-L3 WITH A STANDARD CONSTRUCT AND UNASSEMBLED TI POLYAXIAL POP-ON SCREWS FOR AN L1 BURST FRACTURE AND LEFT RADICULOPATHY ON (B)(6) 2016. DURING THE CASE, THE HEADS WERE BEING PUT ON THE SCREWS WITH THE HEAD APPLICATION INSTRUMENT. THE SURGEON EXPERIENCED DIFFICULTY WITH PLACEMENT OF ONE OF THE HEADS. THE INSTRUMENT WOULD NOT ALLOW ATTACHMENT OF THE HEAD ONTO THE SCREW. THE SURGEON IMMEDIATELY NOTED THE ISSUE WITH THE INSTRUMENT AND SWITCHED TO ANOTHER HEAD APPLICATION INSTRUMENT THAT WAS FUNCTIONING PROPERLY AND CONTINUED TO PLACE ALL THE HEADS ON THE SCREWS SUCCESSFULLY. THERE WAS NO DELAY IN SURGERY AND ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. ROUTINE FLUOROSCOPY IMAGES STANDARD FOR THE PROCEDURE WERE TAKEN AT THE BEGINNING AND END OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. AFTER THE CASE, BOTH OF THE INSTRUMENTS WERE COMPARED, AND ONE OF THEM AT THE BOTTOM END LOOKED DIFFERENT THAN THE OTHER ONE THAT WAS WORKING. ON THE BACK TABLE, THE HEAD WOULD NOT ATTACH TO THE SCREW. IT WAS NOTED THAT IN THE MIDDLE OF T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6266551 ↗
• MalfunctionJan 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SMALL SILVER COMPONENT ON THE TIP OF THE SHAFT OF THE POLYAXIAL HEAD PLACEMENT TOOL POPPED OFF DURING STERILE PROCESSING. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6256375 ↗
• MalfunctionDec 30, 2016Break; Break

  IT WAS REPORTED THAT THE TIPS WERE BROKEN ON THE POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX AND SELF-RETAINING SCREWDRIVER FOR QUICK LOCKS SCREWS. THIS WAS NOTICED DURING INSPECTION AND NOT IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6216349 ↗