Matrix 03.632.074Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705034719184), received between Jan 5, 2017 and Nov 24, 2022 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A REMOVAL CASE FOR A T2-L2 USSII AND URS SPINAL IMPLANT CASE, THE SURGEONS FOUND THAT THE T-HANDLE IN QUESTION WAS DAMAGED BEYOND REPAIR. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860761 ↗
• 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 T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742868 ↗
• MalfunctionApr 22, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PART BROKE INTO THREE PIECES DURING A METAL REMOVAL. THE BONDING / WELDING HAS PROBABLY DISSOLVED. SURGERY COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT. NO FRAGMENTS WERE CREATED. THIS COMPLAINT INVOLVES ONE (1) DEVICE SCRDRIVER T25 LONG W/T-HANDLE F/MATRIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187913 ↗
• MalfunctionDec 28, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A TLIF PROCEDURE THE MATRIX T-HANDLE STARTED TO SWIVEL WHEN IT SHOULD HAVE REMAINED FIXED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13100013 ↗
• MalfunctionDec 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, A DISTAL TIP OF THE SCREWDRIVER BROKE OFF, DURING A MATRIX PEDICLE SCREW SYSTEM REMOVAL AND EXTENSION OF FUSION CASE. FRAGMENTS WERE GENERATED WHICH WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. SURGEON USED A METAL CUTTING BURR, TO REMOVE THE CONSTRUCT. THE SURGERY WAS DELAYED FOR TWENTY (20) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12939469 ↗
• MalfunctionNov 19, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SLOVENIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020 DURING THE FINAL TIGHTENING OF THE MATRIX LOCKING CAP, THE SCREWDRIVER BROKE. FRAGMENTS WERE GENERATED AND THREE FRAGMENTS WERE REMOVED FROM THE PATIENT. IT WAS COMMENTED THAT THIS SCREWDRIVER WAS BEING USED FOR FINAL TIGHTENING INSTEAD OF THE USUAL SCREWDRIVER WITH A TORQUE LIMIT 10 NM. THERE WAS AN UNKNOWN AMOUNT OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN MATRIX LOCKING CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) UNKNOWN TORQUE DEVICES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10869292 ↗
• InjuryJan 28, 2020Material Integrity Problem; Separation Problem; Material Integrity Problem; Separation Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SCREWDRIVER SHAFT TIP HAD SHEARED IN THE HEAD OF THE SCREW ON PEDICLE SCREW INSERTION. NO LOOSE METAL TIP FRAGMENTS WERE FOUND IN THE SURGICAL SITE. UNABLE TO VISUALIZE SCREW HEAD TO CONFIRM METAL TIP PIECES WERE LODGED INTO THE RECESS OF THE SCREW HEAD. THE SURGEON DISCUSSED OPTIONS FOR SCREW REMOVAL BUT WAS CONTENT TO CONTINUE WITH PROCEDURE. THE ROD AND SET SCREWS WERE SECURED UNIMPEDED BY ANY POSSIBLE METAL FRAGMENTS. CONCOMITANT DEVICE REPORTED: DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/ MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9638644 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE T-HANDLE T25 STARDRIVE SHAFT FOR MATRIX-LONG WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246826 ↗
• MalfunctionOct 28, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A SCREWDRIVER SHAFT WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246730 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION, IT WAS OBSERVED THAT THE T-HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204673 ↗
• MalfunctionOct 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER SHAFT SNAPPED OFF THE HANDLE. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9140222 ↗
• MalfunctionSep 17, 2019Break; Break

  CONCOMITANT DEVICE REPORTED: UNKNOWN HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1).

  Patient problems: No Patient Involvement

  MAUDE report 9078035 ↗
• MalfunctionAug 30, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT L2-4 REVISION POSTERIOR LUMBAR FUSION (PLF) SURGERY DUE TO AN INSECURE CONSTRUCT. THE LEFT L2 LOCKING CAP HAD COME OUT OF THE SCREW HEAD AND WAS FLOATING IN SOFT TISSUE, THUS REVISION SURGERY WAS NEEDED. PRIMARY IMPLANT DATE WAS (B)(6) 2012. DURING THE REVISION PROCEDURE THE GREEN T HANDLE SHAFT BROKE OFF WHEN TRYING TO LOOSEN A LOCKING CAP ON THE RIGHT L2 SCREW. THE CAP WAS COLD WELDED TO THE SCREW HEAD AND UNABLE TO BE REMOVED SO THE ROD WAS CUT AND THEN THE SURGEON WAS ABLE TO USE A NIBBLER TO SPIN THE SCREW OUT. THERE WAS TEN (10) MINUTES SURGICAL DELAY IN THE PROCEDURE. THE REVISION PROCEDURE WAS SUCCESSFUL. THIS REPORT CAPTURES THE INTRA-OP EVENT OF THE T-HANDLE BREAKAGE, WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POST-OP EVENT OF THE LOCKING CAP BACK OUT. THIS REPORT IS FOR ONE (1) T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951317 ↗
• MalfunctionJul 30, 2018Break; Break

  THERE WAS NO SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE SAFE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733190 ↗
• MalfunctionJun 21, 2018Peeled/Delaminated; Peeled/Delaminated

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER WAS IN POOR QUALITY. THE THREADED TIP OF THE DEVICE IS DAMAGED. THERE WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AS THEY HAD TWO DEVICES ON THE SET. THE TIP OF THE SCREWDRIVER IS STRIPPED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7625721 ↗
• MalfunctionJan 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT TWO T-HANDLES WERE FOUND WITH THE GREEN HANDLE BECOMING LOOSE/UN-THREADING FROM THE METAL SHAFT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR A T-HANDLE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168642 ↗
• MalfunctionJan 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF FIELD EQUIPMENT TWO T-HANDLES WERE FOUND WITH THE GREEN HANDLE BECOMING LOOSE/UN-THREADING FROM THE METAL SHAFT. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR A T-HANDLE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168630 ↗
• MalfunctionDec 29, 2017Break; Break

  IT WAS REPORTED THAT A SURGEON ATTEMPTED TO INSERT THE PEDICLE SCREW INTO DENSE/HARD BONE, THE TIP OF THE SCREWDRIVER BROKE INTO A FEW PIECES AND THE MALE THREADED END OF THE HOLDING SLEEVE BROKE. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO DELAY UTILIZING SIMILIAR INSTRUMENT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7154212 ↗
• MalfunctionJul 6, 2017Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY TO EXPAND A PREVIOUSLY IMPLANTED MATRIX CONSTRUCT, THE TIP OF A SYNTHES SCREWDRIVER BROKE OFF WHILE THE SURGEON WAS ATTEMPTING TO REMOVE A MATRIX LOCKING CAP. THE BROKEN TIP WAS RETAINED IN THE LOCKING CAP BUT WAS REMOVED EASILY AND DID NOT FALL INTO THE PATIENT. THE PATIENT WAS INITIALLY IMPLANTED ON AN UNKNOWN DATE WITH MATRIX DEVICES AT THE L4-S1 LEVELS, AND THIS REVISION WAS SCHEDULED TO EXTEND THE CONSTRUCT TO INCLUDE THE T10 -S1 LEVELS. THE REVISION WAS SCHEDULED BECAUSE THE PATIENT IS MORBIDLY OBESE WITH SEVERE STENOSIS AFTER THE SURGEON WAS REVIEWING X-RAY IMAGES DURING A ROUTINE FOLLOW-UP APPOINTMENT. THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH ANOTHER SCREWDRIVER AND NO SURGICAL DELAYS OR ADVERSE EVENTS WERE REPORTED. CONCOMITANT DEVICE REPORTED: TI MATRIX LOCKING CAP (PART 04.632.000, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6689141 ↗
• MalfunctionMay 2, 2017Dull, Blunt; Dull, Blunt

  IT IS REPORTED DURING ROUTINE INSPECTION OF DEVICES, THE TIPS OF THREE (3) MATRIX SCREWDRIVER SHAFTS WERE FOUND TO BE STRIPPED. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIX STARDRIVE SHAFT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6537631 ↗
• MalfunctionMay 2, 2017Dull, Blunt; Dull, Blunt

  IT IS REPORTED DURING ROUTINE INSPECTION OF DEVICES, THE TIPS OF THREE (3) MATRIX SCREWDRIVER SHAFTS WERE FOUND TO BE STRIPPED. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIX STARDRIVE SHAFT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6537560 ↗
• MalfunctionMay 2, 2017Dull, Blunt; Dull, Blunt

  IT IS REPORTED DURING ROUTINE INSPECTION OF DEVICES, THE TIPS OF THREE (3) MATRIX SCREWDRIVER SHAFTS WERE FOUND TO BE STRIPPED. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIX STARDRIVE SHAFT THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6537369 ↗
• MalfunctionMay 2, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THE STARDRIVE SCREWDRIVER SHAFT WAS RECEIVED AT THE DEPUY SYNTHES AFFILIATE IN (B)(4) WITH THE HANDLE TIP BROKEN. IT IS NOT KNOWN HOW DEVICE WAS BROKEN OR IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6537260 ↗
• MalfunctionMay 1, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY ON (B)(6) 2017 USING THE MATRIX AND TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR (TPAL) SYSTEMS. THE SURGEON PLACED THE SCREWS FROM L4 TO S1 BILATERALLY SUCCESSFULLY. HE THEN STARTED ON THE TLIF AT THE L5-S1 DISC SPACE. THE SURGEON TRIALED AND IMPLANTED A 9MM TPAL IMPLANT. WHEN IT CAME TO DISENGAGE THE IMPLANT, THE SURGEON HAD A VERY DIFFICULT TIME. THE BACK END OF THE INSERTER STYLET BROKE OFF INSIDE OF THE TPAL APPLICATOR KNOB CAUSING DIFFICULTY DISENGAGING THE IMPLANT FROM THE INSERTER. THESE EVENTS DID RESULT IN A 4 MINUTE SURGICAL DELAY. THE SURGEON WAS ABLE TO EVENTUALLY REMOVE THE TPAL HANDLE WHILE THE INSERTER STYLET REMAINED ATTACHED. HE WAS TWISTING THE INSERTER STYLET AND PULLING UNTIL EVENTUALLY ONE OF THE CLAWS OF THE TIP BROKE OFF. THIS ALLOWED THE SURGEON TO TAKE THE INSERTER STYLET OUT OF THE WOUND. HE THEN RETRIEVED THE BROKEN PIECE OF THE CLAW FROM THE TIP OF THE INSERTER FROM THE WOUND AND PLACED IT ON THE BACK TABLE. THEN SURGEON THEN CONDUCTED ANOTHER TLIF AT THE L4-5 LEVEL WITH SUCCESS FOLLOWED BY THE PLACEMENT OF THE RODS AND LOCKING CAPS. HE THEN FINAL TIG

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534597 ↗
• MalfunctionMar 1, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TEMPORARY IMPLANT OF A SYNTHES MATRIX HARDWARE ON AN UNSPECIFIED DATE IN (B)(6) 2016. THE PATIENT WAS ASYMPTOMATIC POSTOPERATIVELY. THE SURGEON PLANNED THE ROUTINE HARDWARE REMOVAL ON (B)(6) 2017. DURING THE REVISION, UPON TRYING TO REMOVE (ONE) 1 PARTICULAR LOCKING CAP USING A MATRIX LOCKING CAP DRIVER, THE CAP WOULD NOT TURN AND THE T HANDLE DRIVER BROKE OFF INTO THE LOCKING CAP. THE SURGEON REMOVED THE FRAGMENT WITH NO PROBLEM, AND ATTEMPTED TO UNLOCK USING THE ALTERNATIVE REMOVAL TECHNIQUE LISTED IN THE TECHNIQUE GUIDE. WHEN USING THIS TECHNIQUE, THE SURGEON USED A DIFFERENT DRIVER. IT ALSO BROKE OFF IN THE HEAD OF THE CAP. THE SURGEON REMOVED THE FRAGMENTS WITH NO PROBLEM. THE SURGEON THEN TRIED TO LOOSEN THE CAP USING ANOTHER STAR DRIVE SHAFT. THE SHAFT BEGAN TO TWIST OR BEND BUT DID NOT BREAK. THE SURGEON THEN OPTED TO USE ROD CUTTERS TO CUT THE ROD CONTAINED WITHIN THAT SCREW AND CAP. HE THEN REMOVED A SMALL ROD SEGMENT, SCREW AND CAP ALL AS ONE UNIT. NOT BEING ABLE TO EASILY UNSCREW THIS LOCKING CAP ADDED APPROXIMATELY 10 MINUTES TO THE CASE. NO OTHER ILL EFFECTS TO THE PATIENT, DUE TO THIS DELAY, WERE REPORTED. THE PATIENT STATUS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6368847 ↗