Matrix 03.632.073Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705034719177), received between Jan 13, 2017 and Dec 21, 2023 — classified as 12 malfunctions.

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

• MalfunctionDec 21, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED DURING A MATRIX REMOVAL PROCEDURE THE CAPS WERE DIFFICULT TO REMOVE AND TWO (2) SCREWDRIVER SHAFTS WERE STRIPPED. A THIRD SHAFT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. THIS REPORT IS FOR A SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371544 ↗
• MalfunctionNov 27, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON NOV 2, 2023 DURING AN UNKNOWN CASE THE DRIVERS HAD STRIPED. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) T25 STARDRV SHAFT F/MATRX CANULATED/LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211905 ↗
• MalfunctionJan 31, 2023Material Integrity Problem; Material Integrity Problem

  THIS REPORT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274791 ↗
• MalfunctionJun 20, 2022Compatibility Problem; Manufacturing, Packaging or Shipping Problem; Compatibility Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING KIT CHECKING BEFORE THE CSSD PROCESS, IT WAS DISCOVERED THAT ALL THREE DRIVERS HAD BURRS THAT PREVENTED SCREWS FROM ATTACHING TO THEM. THIS REPORT IS FOR A T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742865 ↗
• MalfunctionJun 20, 2022Compatibility Problem; Manufacturing, Packaging or Shipping Problem; Compatibility Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING KIT CHECKING BEFORE THE CSSD PROCESS, IT WAS DISCOVERED THAT ALL THREE DRIVERS HAD BURRS THAT PREVENTED SCREWS FROM ATTACHING TO THEM. THIS REPORT IS FOR A T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742859 ↗
• MalfunctionNov 30, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A MATRIX MIS PROCEDURE, SEVERAL INSTRUMENTS WERE DAMAGED. TWO (2) ROD INTRODUCERS COULD NO LONGER PROPERLY HOLD THE RODS MAKING IT DIFFICULT FOR PATIENT INSERTION. THE SCREWDRIVER SHAFT WAS STRIPPED AT THE DISTAL END TIP. THE ROD PERSUADER COULD NO LONGER HOLD ITS POSITION ONCE ENGAGED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923107 ↗
• MalfunctionSep 11, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MATRIX MIS COMBINED WITH A REGULAR MATRIX CASE ON (B)(6) 2020, ISSUES OCCURRED FOR INSERTING THE CAPS (WHERE ALL OF THE SHAFT AND SPORTS GRIP SHAFT WERE NO LONGER HOLDING THE SET SCREW) AS THE DISTAL END TIP WAS DAMAGED/ SLIGHTLY STRIPPED. ALSO, DURING THE FINAL TIGHTENING, THE CANNULATED AND REGULAR LONG SHAFT STRIPPED AT THE DISTAL END TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SCREWDRIVER SHAFT T25 CANNULATED LONG. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521305 ↗
• MalfunctionFeb 24, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT DR. WEBER WAS PERFORMING A MATRIX MIS FUSION AND WHILE HE WAS ATTEMPTING TO FURTHER INSERT A SCREW, TWO OF THE SELF RETAINING SLEEVES WERE DAMAGED WHERE THE DISTAL END TIP RINGS (WHERE IT SCREWS TO THE HEAD OF THE SCREW) GOT STRIPPED. AS WELL, ONE CANNULATED AND NON-CANNULATED SHAFTS GOT STRIPPED AT THE DISTAL END TIP DUE TO FINAL TIGHTENING. NOTHING FELL INTO THE PATIENT. THE PATIENT WAS NOT IMPACTED BY THIS, THEREFORE NO PATIENT INFORMATION WAS OBTAINED. NO DELAYS WERE OBTAINED AS THE SURGEON USED ALTERNATE INSTRUMENTS FROM THE MATRIX MIS SYSTEM. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744945 ↗
• MalfunctionOct 31, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  CONCOMITANT DEVICE REPORTED: UNK - SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), CAP GUIDE ONE-STEP LONG (PART# 03.616.052; LOT# 8159511; QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261891 ↗
• MalfunctionSep 10, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES CANADA REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SPINE (MIS) FUSTION PROCEDURE ON (B)(6) 2018 UTILIZING MATRIX MIS SYSTEM, THE SURGEON NOTICED THAT THE SCREWS WERE POORLY INSERTING INTO THE PEDICLE. ONCE THE CASE WAS COMPLETED, THE SCRUB NURSE NOTICED THAT BOTH STANDARD AND LONG CANNULATED SCREWDRIVER SHAFTS WERE SLIGHTLY STRIPPED AND TWISTED AT THE DISTAL END TIP. THERE WAS NO DELAYED OBTAINED DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO DELAY. PATIENT WAS NOT AFFECTED BY THIS DAMAGE. CONCOMITANT DEVICE REPORTED: LOCKING/SET SCREWS: MATRIX (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LONG CANNULATED STARDRIVE SHAFT FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862894 ↗
• MalfunctionOct 11, 2017Dull, Blunt; Dull, Blunt

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NURSE WAS PERFORMING A SPINAL SETUP FOR AN MINIMALLY INVASIVE SURGERY (MIS) DEGENERATIVE LUMBAR POSTERIOR FUSION AT L4-S1 ON (B)(6) 2017. DURING INSPECTION OF THE INSTRUMENTS, IT WAS NOTICED THAT TWO (2) SCREWDRIVERS WERE SLIGHTLY DAMAGED. THE T25 STARDRIVE SHAFT FOR MATRIX LONG AND THE T25 STARDRIVE SHAFT FOR MATRIX CANNULATED/LONG WERE SLIGHTLY STRIPPED AT THE DISTAL END. THE ISSUES WERE DISCOVERED PRIOR TO USE ON THE PATIENT AND NOT DURING THE PROCEDURE. NO PATIENT WAS AFFECTED BY THESE INSTRUMENTS. NO SURGERIES WERE IMPACTED BY THESE INSTRUMENTS. NO SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH OTHER SCREWDRIVERS SHAFTS PRESENT IN THE SYSTEM. THIS REPORT IS FOR ONE (1) T25 STARDRIVE SHAFT FOR MATRIX CANNULATED/LONG THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6939755 ↗
• MalfunctionJan 13, 2017Material Deformation; Material Deformation

  (B)(6) REPORTED THAT DURING A LUMBAR MATRIX MIS (MINIMALLY INVASIVE SPINE) FUSION ON (B)(6) 2016, THE SCREWDRIVER STRIPPED AT THE DISTAL TIP WHILE ADJUSTING THE POSITION OF ONE OF THE SCREWS. THE SURGEON CORRECTED THE POSITION OF THE SCREW USING THE SAME SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, AND NO REPORTED HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN MATRIX SCREW (QTY. 1).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6249044 ↗