Matrix 03.632.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10705034718941), received between Dec 13, 2016 and Nov 21, 2025 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621702 ↗
• MalfunctionNov 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 UPON POST OPERATIVE INSPECTION THE SCREWDRIVERS WERE NOTED TO BE STRIPPED AND BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621413 ↗
• MalfunctionOct 24, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRA OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23385282 ↗
• MalfunctionAug 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON JULY 16, 2024, THE OUTER SLEEVE FOR THE MATRIX DRIVER APPEARED TO BE UNCOILING AT THE DISTAL TIP. NO FRAGMENTS WERE PRODUCED. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19939843 ↗
• MalfunctionJan 30, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE MATRIX DEGEN SET HAD TWO WORN SLEEVES WHICH ARE NOT USABLE TO CONNECT TO SCREW AS THE THREADS ON THE TIP ARE UNCOILING. NO OTHER INFORMATION WAS GIVEN. THIS REPORT IS FOR ONE (1) RETAIN-SLEEVE LONG F/MATRIX 5.5 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18607415 ↗
• MalfunctionJan 30, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE MATRIX DEGEN SET HAD TWO WORN SLEEVES WHICH ARE NOT USABLE TO CONNECT TO SCREW AS THE THREADS ON THE TIP ARE UNCOILING. NO OTHER INFORMATION WAS GIVEN. THIS REPORT IS FOR ONE (1) RETAIN-SLEEVE LONG F/MATRIX 5.5 THIS IS REPORT 1 OF 2 FOR COMPLAINT(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18607386 ↗
• MalfunctionJan 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING POST-OP AFTER INSERTION OF A MATRIX SCREW, ONE OF THE THREADS ON THE DISTAL PART OF THE OUTER SLEEVE SEPARATED FROM THE REST, LEAVING A SHARP TIP. THERE WAS NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150774 ↗
• MalfunctionJan 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON 21-DECEMBER-2022 DURING POST-OP AFTER INSERTION OF A MATRIX SCREW, ONE OF THE THREADS ON THE DISTAL PART OF THE OUTER SLEEVE SEPARATED FROM THE REST, LEAVING A SHARP TIP. THERE WAS NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150336 ↗
• MalfunctionDec 6, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHEN USING THE SCREWDRIVER TO INSERT SCREWS, ON THE THIRD SCREW OUT OF FOUR (1 LEVEL TLIF PROCEDURE), THE SCREWDRIVER SLEEVE WAS STUCK IN THE PEDICLE IN ADDITION TO THE GUIDEWIRE. IT WAS REMOVED WITH SOME EFFORT BY THE SURGEON. A BIT OF THE THREAD OF THE SCREWDRIVER WAS CAUGHT IN THE HEAD OF THE SCREW, WHICH WAS NOTED AND EASILY REMOVED WITH A FORCEPS. NO FURTHER FRAGMENTS IN THE PATIENT WERE NOTED. ANOTHER SCREWDRIVER SLEEVE WAS USED TO INSERT THE REMAINING SCREWS. THE PATIENT WAS FINE, AND X-RAY WAS DONE TO CONFIRM THAT NO FURTHER FRAGMENTS WERE LEFT. IT WAS NOTED THAT THE PATIENT HAD HAD A PREVIOUS LAMI DONE IN (B)(6) 2022. SCAR TISSUE WAS PRESENT AND THE BONE WAS NOTED TO BE QUITE HARD TO ACCESS. THE SURGEON HAD DIFFICULTY PREPPING THE PEDICLES PRIOR TO SCREW INSERTION. SURGERY WAS DELAYED BY 2 MINUTES IN RELATION TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925619 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FEW PRODUCTS WERE FOUND DAMAGED WHEN GOING THROUGH THE STERILE PROCESSING DEPARTMENT. THE TIP OF A T25 STARDRIVE SHAFT F/MATRIX STANDARD IS SLIGHTLY STRIPPED AND WILL NOT PROPERLY INTERFACE WITH A SCREW. A HOLDING SLEEVE-LONG FOR MATRIX'S TIP IS SHEARED OFF. THE LOCATION OF THE SHEARED OFF TIP IS UNKNOWN. THIS REPORT IS FOR A HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15448310 ↗
• MalfunctionJul 18, 2022Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047817 ↗
• MalfunctionMay 19, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A REVISION OF LIFE HEALTH CARE IMPLANTS/SCREWS REPLACING WITH SYNTHES AND EXTENDING. AT BEGINNING OF THE CASE DURING SET UP IT WAS NOTED THAT ONE OUT OF THE TWO SCREW DRIVER SLEEVE'S THREAD WAS FAULTY (CANNOT LOAD A SCREW ON STRAIGHT). THEN DURING THE PROCEDURE WHEN SURGEON WAS INTRODUCING THE CANNULATED SCREW INTO THE PEDICLE VIA GUIDEWIRE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK. THE REPORTED SLEEVE HAD ADVANCED NOT ONLY THE SCREW BUT ALSO THE GUIDEWIRE INTO THE PEDICLE. THE SURGEON WAS ABLE TO REMOVE THE GUIDEWIRE WITH SOME FORCE AND NO HARM WAS CAUSED TO PATIENT. UPON INSPECTION IT WAS NOTED THAT THE SLEEVE THREAD WAS OUT OF PLACE/FAULTY. TOTAL OF TWO DRIVER SLEEVES WERE REPORTED FAULTY DURING THIS CASE. THERE WAS A FIVE (5) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442944 ↗
• MalfunctionMay 19, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT UNDERWENT A REVISION OF LIFE HEALTH CARE IMPLANTS/SCREWS REPLACING WITH SYNTHES AND EXTENDING. AT BEGINNING OF THE CASE DURING SET UP IT WAS NOTED THAT ONE OUT OF THE TWO SCREW DRIVER SLEEVE'S THREAD WAS FAULTY (CANNOT LOAD A SCREW ON STRAIGHT). THEN DURING THE PROCEDURE WHEN SURGEON WAS INTRODUCING THE CANNULATED SCREW INTO THE PEDICLE VIA GUIDEWIRE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK. THE REPORTED SLEEVE HAD ADVANCED NOT ONLY THE SCREW BUT ALSO THE GUIDEWIRE INTO THE PEDICLE. THE SURGEON WAS ABLE TO REMOVE THE GUIDEWIRE WITH SOME FORCE AND NO HARM WAS CAUSED TO PATIENT. UPON INSPECTION IT WAS NOTED THAT THE SLEEVE THREAD WAS OUT OF PLACE/FAULTY. TOTAL OF TWO DRIVER SLEEVES WERE REPORTED FAULTY DURING THIS CASE. THERE WAS A FIVE (5) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14442941 ↗
• MalfunctionSep 2, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR SPINAL FUSION, THE MATRIX DRIVER SLEEVE WAS JAMMING WHEN REMOVING THE SCREW WITH TWO OR THREE THREADS STILL THREADED IN THE BONE SCREW HEAD. THE SCREW WAS NOT LOADED STRAIGHT ON THE DRIVER AND WAS ATTEMPTED TO ADVANCE THE SLEEVE EITHER FORWARD OR BACKWARD WITHOUT ANY MOVEMENT. AFTER THE PROCEDURE ENDED, THE BONE SCREW WAS REMOVED FROM THE DRIVER AND AFTER THE THREADS WAS INSPECTED, IT APPEARED STRIPED. THEN THE SURGEON USED A NEW SCREW AND ATTEMPTED TO THREAD THE DRIVER SLEEVE INTO THE BONE SCREW. IT JAMMED APPROXIMATELY 3/4 OF THE WAY THREADED. WHEN THE SURGEON WENT TO REMOVE THE SLEEVE FROM THE BONE SCREW, THE THREADS AGAIN JAMMED WITH APPROXIMATELY 1/4 OF THE THREADS TO GO. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414787 ↗
• MalfunctionJul 1, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A DR. WAS PERFORMING A MATRIX LUMBAR FUSION AND UPON INSERTING THE SACRO-ILIAC SCREWS, THE SCREWDRIVER RETAINING SLEEVE BROKE AT THE DISTAL END TIP. THE END THREADS BECAME UNDONE,. THE NURSE DISCARDED THE SLEEVES. IT WAS ALSO REPORTED THAT NOTHING FELL INTO THE PATIENTS, AS THERE WERE NO DELAYS DURING THE SURGERY AND THE SHORT RETAINING SLEEVES WERE USED FOR THE REMAINDER OF THE CASE. THERE IS NO MORE INFORMATION TO PROVIDE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099866 ↗
• MalfunctionJul 1, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DR. WAS PERFORMING A MATRIX LUMBAR FUSION AND UPON INSERTING THE SACRO-ILIAC SCREWS, THE SCREWDRIVER RETAINING SLEEVE BROKE AT THE DISTAL END TIP. THE END THREADS BECAME UNDONE,. THE NURSE DISCARDED THE SLEEVES. IT WAS ALSO REPORTED THAT NOTHING FELL INTO THE PATIENTS, AS THERE WERE NO DELAYS DURING THE SURGERY AND THE SHORT RETAINING SLEEVES WERE USED FOR THE REMAINDER OF THE CASE. THERE IS NO MORE INFORMATION TO PROVIDE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099865 ↗
• MalfunctionMay 6, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL FUSION, THE SURGEON ATTEMPTED TO PLACE A MATRIX SCREW, AND THE SCREW WOULDN¿T ADVANCE. THE SURGEON HAD TO BACK IT OUT, AND THE SCREW WOULDN¿T COME OFF OF THE DRIVER. IT FINALLY BROKE OFF THE TIP OF THE OUTER SLEEVE. THE PATIENT HAD A VERY DENSE BONE. THE SURGEON USED A DIFFERENT DRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE MINUTE SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784656 ↗
• MalfunctionApr 26, 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 PRE SURGERY INSPECTION, IT WAS NOTICED THAT A PIECE HAS BROKEN OFF AT THE FRONT OF THE THREAD OF THE INSTRUMENT. SURGERY WAS COMPLETED WITH A SECOND AVAILABLE INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724694 ↗
• MalfunctionDec 2, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SPONDYLODESIS PROCEDURE TWO INSTRUMENTS BROKE WHEN INSERTING THE IMPLANTS. THE LONG OUTER RETAINING SLEEVE BROKE WHEN INSERTING THE MATRIX POLYAXIAL SCREW. THE THREADED PART WOULD NOT ENGAGE WHOLLY INTO THE HEAD OF THE SCREW AND IT BROKE OFF. ANOTHER RETAINING SLEEVE WAS USED TO FINISH THE INSERTION. THE SCREWDRIVER ALSO BROKE WHEN LOCKING THE END CAPS DESPITE BEING USED WITH THE TORQUE LIMITING ATTACHMENT. THE PART OF THE SCREWDRIVER THAT BROKE OFF HAD TO BE RETRIEVED FROM THE PATIENT. TWO (2) ADDITIONAL HOLDING SLEEVE-LONG FOR MATRIX WERE SUBMITTED AS PART OF THIS COMPLAINT SINCE THE CONDITIONS UNDER WHICH THEY BROKE ARE VERY SIMILAR TO THE EVENTS IN THIS COMPLAINT. CONCOMITANT DEVICES: UNKNOWN MATRIX POLYAXIAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN END- CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931841 ↗
• MalfunctionDec 2, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SPONDYLODESIS PROCEDURE TWO INSTRUMENTS BROKE WHEN INSERTING THE IMPLANTS. THE LONG OUTER RETAINING SLEEVE BROKE WHEN INSERTING THE MATRIX POLYAXIAL SCREW. THE THREADED PART WOULD NOT ENGAGE WHOLLY INTO THE HEAD OF THE SCREW AND IT BROKE OFF. ANOTHER RETAINING SLEEVE WAS USED TO FINISH THE INSERTION. THE SCREWDRIVER ALSO BROKE WHEN LOCKING THE END CAPS DESPITE BEING USED WITH THE TORQUE LIMITING ATTACHMENT. THE PART OF THE SCREWDRIVER THAT BROKE OFF HAD TO BE RETRIEVED FROM THE PATIENT. TWO (2) ADDITIONAL HOLDING SLEEVE-LONG FOR MATRIX WERE SUBMITTED AS PART OF THIS COMPLAINT SINCE THE CONDITIONS UNDER WHICH THEY BROKE ARE VERY SIMILAR TO THE EVENTS IN THIS COMPLAINT. CONCOMITANT DEVICES: UNKNOWN MATRIX POLYAXIAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN END- CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931749 ↗
• MalfunctionNov 30, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, 2 SCREWDRIVER SLEEVES RETAINING-MATRIX DAMAGED CONSECUTIVELY WHILE INSERTING SCREWS INTO BONE. SURGEON HEARD METAL STRIPPING SOUNDS, RELEASED THE SCREWDRIVER FROM THE IMPLANT ONCE IT WAS FULLY IMPLANTED IN THE PEDICLE, TO FIND SMALL METAL STRIP WAS RETRIEVED AND DISPOSED. THE SECOND DRIVER WAS USED TO LOAD CONSECUTIVE SCREW AND THE SAME THING HAPPENED, THREADED PORTION OF RETAINING SLEEVE BROKE OFF WHILE IMPLANTING THE SCREW. THERE WAS FRAGMENT GENERATED. IT WAS UNKNOWN IF FRAGMENT REMOVED. THE SURGERY WAS COMPLETED WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923370 ↗
• MalfunctionNov 30, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, 2 SCREWDRIVER SLEEVES RETAINING-MATRIX DAMAGED CONSECUTIVELY WHILE INSERTING SCREWS INTO BONE. SURGEON HEARD METAL STRIPPING SOUNDS, RELEASED THE SCREWDRIVER FROM THE IMPLANT ONCE IT WAS FULLY IMPLANTED IN THE PEDICLE, TO FIND SMALL METAL STRIP WAS RETRIEVED AND DISPOSED. THE SECOND DRIVER WAS USED TO LOAD CONSECUTIVE SCREW AND THE SAME THING HAPPENED, THREADED PORTION OF RETAINING SLEEVE BROKE OFF WHILE IMPLANTING THE SCREW. THERE WAS FRAGMENT GENERATED. IT WAS UNKNOWN IF FRAGMENT REMOVED. THE SURGERY WAS COMPLETED WITH 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923331 ↗
• MalfunctionNov 23, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A SPONDYLODESIS PROCEDURE TWO INSTRUMENTS BROKE WHEN INSERTING THE IMPLANTS. THE LONG OUTER RETAINING SLEEVE BROKE WHEN INSERTING THE MATRIX POLYAXIAL SCREW. THE THREADED PART WOULD NOT ENGAGE WHOLLY INTO THE HEAD OF THE SCREW AND IT BROKE OFF. ANOTHER RETAINING SLEEVE WAS USED TO FINISH THE INSERTION. THE SCREWDRIVER ALSO BROKE WHEN LOCKING THE END CAPS DESPITE BEING USED WITH THE TORQUE LIMITING ATTACHMENT. THE PART OF THE SCREWDRIVER THAT BROKE OFF HAD TO BE RETRIEVED FROM THE PATIENT. CONCOMITANT DEVICES: UNKNOWN MATRIX POLYAXIAL SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN END- CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10887938 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THAT THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SURGEON WAS PERFORMED A L3-5 POSTERIOR LATERAL FUSION WITH BILATERAL PEDICLE SCREWS BUT THE TIP OF THE L5 SCREW WAS BROKEN OFF. THE INSTRUMENT WAS IMMEDIATELY SWAPPED OUT FOR A NEW SLEEVE AND ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN PEDICLE SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10433861 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED THAT DURING AN L3-L5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2020, AFTER THE CAGES WERE INSERTED, THE SURGEON BEGAN INSERTING THE BILATERAL PEDICLE SCREWS FROM L3-L5. WHILE INSERTING THE L4 PEDICLE SCREWS ON THE RIGHT SIDE, THE MATRIX HOLDING SLEEVE WAS NOTICED TO START STRIPING AT THE DISTAL TIP WHERE THE THREADED PORTION ENGAGES WITH THE MATRIX HEADLESS SCREWS. ANOTHER SLEEVE WAS USED, AND THE SCREW WAS IMPLANTED WITHOUT ISSUE. THE SAME THING HAPPENED ON THE NEXT LEVEL L5 ON THE RIGHT. THIS TIME A SMALL FRAGMENT BROKE OFF, HOWEVER, ALL PIECES WERE REMOVED FROM THE PATIENT. A THIRD SLEEVE WAS USED, AND THE SCREWS WERE PLACED WITHOUT ANY ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: MATRIX PEDICLE SCREW (PART # 04.639.745), UNKNOWN CAGE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREWDRIVER SHAFT (PART # UNKNOWN, LOT UNKNOWN, QUANTITY 1), UNKNOWN T-HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-LONG FOR MATRIX. THIS IS REPORT 01 OF 02 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315695 ↗