Matrix 03.632.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705034718668), received between Dec 15, 2016 and Aug 23, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) WAS PERFORMED ON (B)(6) 2023. THE SLEEVES AND SCREWS GOT DAMAGED. THE SLEEVES COULD NOT GRASP THE SCREWS, PERHAPS BECAUSE THE SLEEVES WERE TURNED WITHOUT ENGAGING WITH THE THREADS ON THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE-STANDARD FOR MATRIX.. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602482 ↗
• MalfunctionAug 23, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) WAS PERFORMED ON (B)(6)2023. THE SLEEVES AND SCREWS GOT DAMAGED. THE SLEEVES COULD NOT GRASP THE SCREWS, PERHAPS BECAUSE THE SLEEVES WERE TURNED WITHOUT ENGAGING WITH THE THREADS ON THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE HOLDING SLEEVE-STANDARD FOR MATRIX.. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602479 ↗
• MalfunctionApr 3, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN INTERBODY FUSION (L3, LEFT) FOR STENOSIS ON (B)(6)2023. THE SURGEON INSERTED THE SCREW AND TRIED TO DETACH IT FROM THE HOLDING SLEEVE, BUT IT DID NOT COME OFF. THE SURGEON TRIED VARIOUS METHODS, BUT THE SCREW DID NOT COME OFF AT ALL. THE SALES REP ASKED THE SURGEON TO REMOVE THE SCREW ONCE. THEN, THE SURGEON INSERTED ANOTHER SCREW USING ANOTHER HOLDING SLEEVE. THE INSERTED SCREW WAS DETACHED FROM THE HOLDING SLEEVE WITH NO PROBLEM. THE DEFECTIVE HOLDING SLEEVE COULD NOT BE DETACHED FROM THE SCREW DURING SURGERY. WHEN THE SALES REP TRIED TO DETACH THE HOLDING SCREW FROM THE SCREW AFTER SURGERY, IT DID NOT COME OFF AT ALL WITH THE USUAL DETACHING METHOD, BUT THE SALE REP WAS FINALLY ABLE TO DETACH THEM BY REPEATED PULLING, ETC. AFTER SEVERAL ATTEMPTS TO DETACH AND ATTACH THE HOLDING SLEEVE AND THE SCREW, THE SCREW WOULD NOT COME OFF THE HOLDING SLEEVE ABOUT 1 OUT OF EVERY 3 TIMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RETAIN-SLEEVE STD F/MATRIX 5.5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665229 ↗
• MalfunctionNov 11, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TLIF (L4 TO L5) FOR DEGENERATIVE DISEASE, WHEN THE SURGEON ATTACHED THE SCREW TO THE SLEEVE, IT DID NOT HOLD STRAIGHT. THEN, THE TIP OF THE SLEEVE WAS BROKEN. THE SURGEON USED REPLACEMENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779373 ↗
• MalfunctionNov 11, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TLIF (L4 TO L5) FOR DEGENERATIVE DISEASE, WHEN THE SURGEON ATTACHED THE SCREW TO THE SLEEVE, IT DID NOT HOLD STRAIGHT. THEN, THE TIP OF THE SLEEVE WAS BROKEN. THE SURGEON USED REPLACEMENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779359 ↗
• MalfunctionOct 14, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A CBT PLIF (L4/5) FOR TREATING SPONDYLOLISTHESIS, A SCREW WAS NOT ABLE TO BE ATTACHED STRAIGHT TO THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. IT WAS POSTOPERATIVELY FOUND THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632495 ↗
• MalfunctionJul 5, 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, THE PATIENT UNDERWENT FOR A PLIF TREATING LUMBAR SPONDYLOLISTHESIS SURGERY. DURING THE SURGERY, THE SURGEON WHILE INSERTING A SCREW WITH THE SLEEVE, THE TIP OF THE SLEEVE FOUND CHIPPED. ALSO, ANOTHER TIP BREAKAGE WAS FOUND ON THE REPLACED SLEEVE. THE SURGERY WAS COMPLETED LESS THAN 30-MINUTES DELAY. THERE WERE NO FRAGMENTS ARE REMAINING IN THE PATIENT. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 2) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116705 ↗
• MalfunctionJul 5, 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, THE PATIENT UNDERWENT FOR A PLIF TREATING LUMBAR SPONDYLOLISTHESIS SURGERY. DURING THE SURGERY, THE SURGEON WHILE INSERTING A SCREW WITH THE SLEEVE, THE TIP OF THE SLEEVE FOUND CHIPPED. ALSO, ANOTHER TIP BREAKAGE WAS FOUND ON THE REPLACED SLEEVE. THE SURGERY WAS COMPLETED LESS THAN 30-MINUTES DELAY. THERE WERE NO FRAGMENTS ARE REMAINING IN THE PATIENT. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 2) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-STANDARD FOR MATRIX . THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116682 ↗
• 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, THE PATIENT UNDERWENT FOR A POSTERIOR SPINAL FUSION AT S1 LEFT TREATING SPONDYLOLISTHESIS. DURING THE SURGERY, THE SCREW WAS NOT ABLE TO BE TIGHTENED. THE SURGEON RETRIED TO CONNECT THE SCREW AND THE SCREWDRIVER OUT OF THE LESION, WHICH WAS FAILED. A CHIPPED FRAGMENT FOUND AFTER POSTOPERATIVE STERILIZATION. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES DELAY. THE PATIENT CONDITION WAS STABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) T25 STARDRIVE SHAFT F/MATRIX STANDARD. THIS REPORT IS 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727482 ↗
• MalfunctionFeb 1, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PLIF AT L5-S FOR TREATMENT OF SPINAL CANAL STENOSIS THE SCREW SPLIT INTO THE SCREWHEAD AND SHAFT WHEN THE SURGEON HAD TO EXTRACT AN INSERTED SCREW. THE SURGEON WAS ABLE TO REMOVE THE TWO FRAGMENTS OF THE SCREW AND THE SLEEVE. IT WAS CONFIRMED THAT NO FRAGMENTS WERE LEFT IN THE PATIENT¿S BODY. THERE WAS A LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM (PART NUMBER 04.632.740S, LOT H641918, QUANTITY 1) THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259815 ↗
• MalfunctionJan 4, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR A PLIF (POSTERIOR LUMBAR INTERBODY FUSION) AT L4 TREATING SPINAL CANAL STENOSIS ON (B)(6) 2020. BEFORE THE PROCEDURE IT WAS FOUND THAT THE SCREW HAD BEEN DAMAGED AND THE TIP OF THE SLEEVE HAD BEEN BROKEN. IT WAS UNKNOWN WHEN AND HOW IT OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) HOLDING SLEEVE-STANDARD FOR MATRIX THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11111713 ↗
• MalfunctionDec 7, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A POSTERIOR SPINAL FUSION PERFORMED ON (B)(6) 2020, THE SURGEON FELT SOMETHING DIFFERENT FROM USUAL MANNER DURING SCREW INSERTION. AS SURGEON WAS INSERTING THE SCREW, HE HEARD LITTLE NOISE, AND HE FINALLY FOUND THAT THE THREADS OF THE SLEEVE HAD CHIPPED. HE CONFIRMED VISUALLY AND BY X-RAY THAT NO FRAGMENT WAS LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH LESS THAN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: LOCKING/SET SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10962067 ↗
• MalfunctionSep 30, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 AN L5 S1 SINGLE LEVEL FUSION WAS PERFORMED USING AN ORTHOKIT LOAN MATRIX SET. DURING THE SECOND SCREW INSERTION, THE TIP OF A SCREW DRIVER BROKE WITH THE FIRST 2 THREADS STRIPPING. DURING INSERTION OF THE THIRD SCREW THE HANDLE OF ANOTHER SCREWDRIVER BROKE CLEAN OFF. A 7 X50MM SCREW WHICH WAS BEING INSERTED WAS DISCARDED AS A SMALL CHARD OF METAL WAS SEEN HANGING FROM ITS HEAD. THE GENERATED SHARDS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3). UNKNOWN T-HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 10605516 ↗
• MalfunctionMay 7, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, ONE OF THE SCREWDRIVER SHAFT STARDRIVE FOR MATRIX WAS STRIPPED AT THE DISTAL END TIP AS WELL AS ONE OF THE RETAINING SLEEVE STANDARD FOR MATRIX WAS ALSO DAMAGED AT THE DISTAL END TIP WHERE THE RINGS WAS STARTING TO WEAR DOWN AND COME OFF DUE TO THE PATIENT HARD BONE DURING A MATRIX POSTERIOR SPINAL FUSION. NO FRAGMENTS WERE GENERATED. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586554 ↗
• MalfunctionDec 4, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, A PATIENT UNDERWENT A SPINAL FUSION SURGERY USING A MATRIX SYSTEM. DURING THE PROCEDURE ONE (1) T25 STARDRIVE SHAFT, STANDARD, ONE (1) HOLDING SLEEVE AND ONE (1) T25 STARDRIVE SHAFT, LONG WERE DAMAGED DUE TO THE FACT THAT THE PATIENT HAD A HARD BONE. THE PATIENT WAS NOT AFFECTED BY THE FACT THAT THE TWO (2) SCREWDRIVERS WERE STRIPPED AT THE DISTAL END TIP AND ONE (1) SCREWDRIVER SLEEVE DISTAL END TIP BROKE AT ONE OF THE END RING. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE SURGERY WAS COMPLETED USING SIMILAR INSTRUMENTS PRESENT IN THE SET. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 2 OF 3 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130874 ↗
• MalfunctionApr 18, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A SURGERY FOR DEGENERATIVE LUMBAR SPONDYLOLISTHESIS WAS PERFORMED. THE FIXED AREA WAS L3-L5. DURING THE SURGERY, THE SURGEON SUCCESSFULLY INSERTED THE SCREW BY USING THE CONNECTED TWO DEVICES. THEN, HE FOUND THAT THE THREAD PART OF RETAIN SLEEVE WAS BROKEN. AS THE SCREW INSERTION WAS SUCCESSFULLY DONE, HE COMPLETED THE SURGERY WITHOUT ANY DELAY. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THERE IS NO COMPLAINT AGAINST THE SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT PARTS: UNKNOWN QUANTITY OF UNKNOWN SCREWS, 1 QTY, PART NUMBER 03.632.005, LOT NUMBER UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7439586 ↗
• MalfunctionMar 30, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO THE START OF A POSTERIOR LUMBAR FUSION (L4-L5), WHILE THE NURSE WAS SETTING UP HER TABLE, SHE NOTED THAT THE TWO (2) STANDARD (SCREWDRIVER) HOLDING SLEEVES FOR MATRIX WERE DAMAGED. REPORTEDLY, THE DISTAL END TIPS OF ONE OF THE DEVICES APPEARED PARTIALLY USED WHILE THE OTHER HAD DISTAL TIP END RINGS THAT WERE COMPLETELY TORN OFF. AS TWO (2) OTHER LONG SLEEVES FOR MATRIX WERE AVAILABLE FOR USE, THERE WAS NO DELAY IN THE SURGERY AND THE PATIENT WAS NOT AFFECTED. THE DAMAGED DEVICES WERE IMMEDIATELY REMOVED FROM THE SET. THIS REPORT IS FOR ONE (1) HOLDING SLEEVE-STANDARD FOR MATRIX. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386819 ↗
• MalfunctionMar 6, 2018Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGERY FOR SPONDYLOLYTIC SPONDYLOLISTHESIS WAS PERFORMED BY USING THE MATRIX SYSTEM AND T-PAL SYSTEM. THE FIXED AREA WAS L5 ¿ S1. WHEN THE SCREW DRIVER WAS REMOVED FROM THE SCREW AFTER THE SCREW AT S1 WAS INSERTED, THE TIP OF THE HOLDING SLEEVE (THREADS PART) BROKE. THE SURGERY WAS COMPLETED WITH NO DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317336 ↗
• MalfunctionJan 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DISTAL END OF TWO (2) SEPARATE SPORT GRIP T25 STARDRIVE SCREWDRIVER SHAFTS ARE SLIGHTLY STRIPPED. IT WAS ALSO NOTED THE SCREWDRIVER SLEEVE HAS A METAL RING DAMAGE, SUSPECTED TO BE DUE TO WEAR AND TEAR. ISSUE WAS DISCOVERED WHILE SCRUB NURSE WAS SETTING UP PRIOR TO SURGERY, NO PATIENT INVOLVEMENT. WHEN THE DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THAT THE DISTAL THREADS WERE PARTIALLY BROKEN OFF THE HOLDING SLEEVE. IT WAS ALSO NOTED THAT THE SCREWDRIVER TIPS HAVE SOME SMALL GOUGES IN THEM. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168497 ↗
• MalfunctionNov 14, 2017Peeled/Delaminated; Peeled/Delaminated

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO SCREWDRIVERS WEREN'T RETAINING THE SCREW PROPERLY DURING A L2-L4 DECOMPRESSION AND FUSION ON (B)(6) 2017. MULTIPLE TRIES WERE UNSUCCESSFUL. BOTH OF THE DRIVERS WERE SHOWN TO HAVE VISIBLE THREAD DAMAGE UPON INSPECTION. THE CASE WAS COMPLETED WITHOUT THE HOLDING SLEEVES. THERE WAS NO REPORTED SURGICAL DELAY, AND NO REPORTED HARM TO THE PATIENT. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER SHAFT STARDRIVE FOR MATRIX (PART # UNKNOWN, LOT # UNKNOWN, QTY. UNKNOWN); UNKNOWN-HANDLE WITH RATCHET WRENCH AND WITH TORQUE LIMITER (PART # UNKNOWN, LOT # UNKNOWN, QTY UNKNOWN); UNKNOWN PEDICLE SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. UNKNOWN). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7030072 ↗
• MalfunctionNov 14, 2017Peeled/Delaminated; Peeled/Delaminated

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO SCREWDRIVERS WEREN'T RETAINING THE SCREW PROPERLY DURING A L2-L4 DECOMPRESSION AND FUSION ON (B)(6) 2017. MULTIPLE TRIES WERE UNSUCCESSFUL. BOTH OF THE DRIVERS WERE SHOWN TO HAVE VISIBLE THREAD DAMAGE UPON INSPECTION. THE CASE WAS COMPLETED WITHOUT THE HOLDING SLEEVES. THERE WAS NO REPORTED SURGICAL DELAY, AND NO REPORTED HARM TO THE PATIENT. THERE ARE TWO DEVICES INVOLVED IN THIS COMPLAINT. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER SHAFT STARDRIVE FOR MATRIX (PART # UNKNOWN, LOT # UNKNOWN, QTY. UNKNOWN); UNKNOWN T-HANDLE WITH RATCHET WRENCH AND WITH TORQUE LIMITER (PART # UNKNOWN, LOT # UNKNOWN, QTY UNKNOWN); UNKNOWN PEDICLE SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY. UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7030033 ↗
• MalfunctionOct 25, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE MATRIX SYSTEM. DURING THE SURGERY, THE SURGEON CONFIRMED THAT THE FOLLOWING PRODUCTS WERE BROKEN AT THE TIME OF INSERTION. 3 PCS OF PEDIC-SCR-MATR 5.5 Ø5.5 L35 TAN, 1 PC OF PEDIC-SCR-MATR 5.5 Ø5.5 L40 TAN, 1 PCS OF RETAIN-SLEEVE STD F/MATRIX 5.5. 1 PC OF SCRDRIVERSHAFT T25 STD F/MATRIX 5.5 IS WORN. THERE WERE NO BROKEN PARTS FOUND LEFT IN THE BODY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. COMPLAINT INVOLVES 6 PART. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976261 ↗
• MalfunctionJun 22, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON WAS PERFORMING A LUMBAR FUSION AND DURING THE ADJUSTMENT OF A SCREW THAT HAD BEEN INSERTED DURING THIS CASE, SOME OF THE THREADS OF THE SCREWDRIVER SLEEVE END TIP CAME OFF. THE PIECES WERE RETRIEVED FROM THE PATIENT AND NOTHING WAS LEFT BEHIND. THE SURGERY DID NOT EXPERIENCE A DELAY AND WAS COMPLETED WITH ANOTHER SLEEVE FOUND IN THE MATRIX SYSTEM. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STANDARD MATRIX HOLDING SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6661827 ↗
• MalfunctionApr 5, 2017Failure To Adhere Or Bond; Device Operates Differently Than Expected; Failure To Adhere Or Bond; Device Operates Differently Than Expected

  SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT AN L1 DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH) TRAUMA LEVELS T10-L4 ON (B)(6) 2017, THE SURGEON COULD NOT HOLD THE SCREW STRAIGHT ON THE RETAINING SLEEVE STANDARD FOR MATRIX 5.5MM. HE ALSO FOUND THAT THE OTHER SCREWS CAME OFF THIS SLEEVE SEVERAL TIMES DURING INSERTION AT THE PEDICLE. THE ATTENDING NURSE ALSO TRIED TO MOUNT SCREWS TO THIS SLEEVE BUT FAILED AS WELL. THE SURGERY WAS DELAYED BY FIVE (5) MINUTES DUE TO THE REPORTED ISSUE. CONCOMITANT DEVICES: SCREWS (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6459723 ↗
• MalfunctionFeb 28, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY PERFORMED ON (B)(6) 2017 FOR THE LUMBAR SPINAL CANAL STENOSIS, THE SURGEON USED A SCREW DRIVER TO FIX THE PEDICLE SCREW. HOWEVER, THE REPORTED SCREW DID NOT FIT AS STRAIGHT INTO THE RETAIN SLEEVE. AFTER CHECKING THE CONCERNED INSTRUMENTS THE SURGEON FOUND THAT THE THREADS OF THE REPORTED SCREW (THE PART WHICH WAS FIT TO THE SLEEVE TIP) WERE DEFORMED AND THE TIP OF THE REPORTED SLEEVE WAS DEFORMED. SURGEON REPLACED THE IMPLANT AND A DRIVER SLEEVE AND COMPLETED THE SURGERY. SURGERY WAS PROLONGED BY THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING THE MANUFACTURER PRELIMINARY INVESTIGATION PROCESS IT WAS IDENTIFIED THAT TIP OF THE RETAIN SLEEVE WAS BROKEN OFF AND NOT DEFORMED. MISSING PIECES WERE NOT RECEIVED IN ADDITION TO THE SLEEVE. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON FEBRUARY 3, 2017. CONCOMITANT REPORTED DEVICE: SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6364841 ↗