EXPEDIUM 279722400Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10705034199344), received between Aug 1, 2017 and Oct 15, 2025 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE SCREWDRIVER TIPS WERE BROKEN WHILE TRYING TO REMOVE A SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302363 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE SCREWDRIVER TIPS WERE BROKEN WHILE TRYING TO REMOVE A SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302276 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PRODUCT WAS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290860 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PRODUCT WAS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290313 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS WORN FROM USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285215 ↗
• MalfunctionDec 17, 2024Break; Break

  IT WAS REPORTED THAT THIS WAS A TLIF (L4) FOR LUMBAR CANAL STENOSIS ON (B)(6) 2024. DURING THE SURGERY, A SCREW WAS TO BE REINSERTED. THE SURGEON ATTACHED THE SCREWDRIVER TO THE SCREW. WHEN THE SURGEON WAS ABOUT TO REMOVE THE SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20950526 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SURGEON WAS HAVING TROUBLE ATTACHING THE REDUCER TO THE READ OF THE SCREWS. AFTER TRYING FOR SOME TIME, THEY MANAGED AND ACHIEVED THE ROD REDUCTION REQUIRED. WHEN THEY HANDED THE INSTRUMENT OUT, IT WAS APPARENT THAT THE MIDDLE PORTION OF THE INSTRUMENT WAS BENT. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN XPDM QUICK-CON DI POLY SCWDRVR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040315 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENTS BONE WAS PARTICULARLY HARD AND THE INSERTIONAL TORQUE WAS TOO HIGH WHEN INSERTING THE PELVIC SCREWS AND THE TIP OF 2 SCREWDRIVERS SNAPPED OFF IN THE SCREWS DURING THE PROCEDURE ON (B)(6) 2024. THE SCREWS WERE REMOVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. AN ALTERNATIVE SCREW AND SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) XPDM QUICK-CON DI POLY SCWDRVR THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636220 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENTS BONE WAS PARTICULARLY HARD AND THE INSERTIONAL TORQUE WAS TOO HIGH WHEN INSERTING THE PELVIC SCREWS AND THE TIP OF 2 SCREWDRIVERS SNAPPED OFF IN THE SCREWS DURING THE PROCEDURE ON (B)(6) 2024. THE SCREWS WERE REMOVED AND NO FRAGMENTS WERE LEFT IN THE PATIENT. AN ALTERNATIVE SCREW AND SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) XPDM QUICK-CON DI POLY SCWDRVR THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19636170 ↗
• MalfunctionSep 26, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY IN 2018 IN WHICH L4 TO S WERE FIXED WITH MATRIX IMPLANTS. AFTER SURGERY, ASD (ADJACENT SEGMENT DISEASE) OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. IN THE REVISION SURGERY, THE MATRIX SCREW AT S WAS FOUND TO BE LOOSE. AND IT WAS TO BE REPLACED WITH THE EXPEDIUMDI10.0×55 SCREW. DURING INSERTION OF THIS SCREW, THE TIP OF THE SCREWDRIVER WAS DAMAGED AND CAUGHT INSIDE THE CORE OF THE EXPEDIUMDI10.0×55, MAKING IT IMPOSSIBLE TO PROCEED WITH SCREW INSERTION. THE EXPEDIUMDI10.0×55 WAS EXTRACTED, AND ANOTHER SCREW (EXPEDIUMDI10.0×45) WAS INSERTED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. UPON INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE SCREWDRIVER WAS BROKEN. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM QUICK CONNECT DI POLY DRIVER. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE ASD AND REVISION SURGERY. THIS REPORT CAPTURES THE SCREW MALFUNCTION ENCOUNTERED DURING SURGERY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816169 ↗
• MalfunctionSep 25, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME INSTRUMENTS WERE OBSERVED TO NOT BE IN GREAT CONDITION WHILE GOING THROUGH/RESTOCKING THE SETS. THERE WAS NO PATIENT INVOLVEMENT/CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM QUICK-CON DI POLY SCWDRVR THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807014 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SOME INSTRUMENTS WERE OBSERVED TO NOT BE IN GREAT CONDITION WHILE GOING THROUGH/RESTOCKING THE SETS. THERE WAS NO PATIENT INVOLVEMENT/CONSEQUENCES. THIS REPORT IS FOR ONE (1) XPDM QUICK-CON DI POLY SCWDRVR. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806994 ↗
• MalfunctionApr 14, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE SCREWDRIVER STRIPPED DURING SCREW INSERTION AND PARTS OF THE TIP BROKE. NO FURTHER INFORMATION PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110854 ↗
• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING THE INSERTION OF ILIAC BOLTS TWO POLYAXIAL SCREWDRIVERS BROKE UNDER PRESSURE; THE TIPS SNAPPED OFF BUT NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN (15) MINUTE DELAY. THIS REPORT IS FOR A POLYAXIAL SCREWDRIVERS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459688 ↗
• MalfunctionSep 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING THE INSERTION OF ILIAC BOLTS TWO POLYAXIAL SCREWDRIVERS BROKE UNDER PRESSURE; THE TIPS SNAPPED OFF BUT NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN (15) MINUTE DELAY. THIS REPORT IS FOR A POLYAXIAL SCREWDRIVERS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459665 ↗
• InjuryAug 25, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2021, ONE SCREWDRIVER HAD ITS TIP BROKEN OFF AND THE OTHER ONE WAS DEFORMED. A PART OF THE BROKEN FRAGMENTS HAS BEEN LEFT IN THE SCREW CORE. THE PROCEDURE WAS DELAYED FOR LESS THAN THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM QUICK CONNECT DI POLY DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12368193 ↗
• MalfunctionFeb 16, 2021Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION TREATING ASD ON AN KNOWN DATE. WHILE THE SCREW WAS BEING INSERTED INTO THE ROBUST BONE WITH THE HELP OF MUCH LOAD, THE TIP OF THE SCREWDRIVER BROKE OFF. ALL THE FRAGMENTS WERE REMOVED EASILY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) XPDM QUICK-CON DI POLY SCWDRVR. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11333512 ↗
• MalfunctionJan 11, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN INSPECTION IT WAS DISCOVERED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THERE WAS NO SURGERY OR PATIENT IMPACT. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM QUICK CONNECT DI POLY DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11151297 ↗
• MalfunctionSep 29, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT S1 TREATING SPONDYLOLISTHESIS, THE SCREWDRIVER TIP BROKE OFF DURING SCREW INSERTION. FRAGMENT(S) BECAME STUCK WITH THE SCREWS SHAFT. THE SURGEON REMOVED THE SCREW AND COMPLETED THE PROCEDURE WITH REPLACEMENTS. THERE WAS A, LESS THAN, 30-MINUTE SURGICAL DELAY. ALL THE FRAGMENTS WERE REMOVED WITH THE SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM QUICK CONNECT DI POLY DRIVER THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599464 ↗
• MalfunctionMar 26, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A POSTERIOR SPINAL FUSION (PSF) PROCEDURE TO TREAT A LUMBAR SPINAL STENOSIS WHILE THE SCREW (179722945) WAS BEING INSERTED INTO THE STURDY BONE, THE TIP OF THE SCREWDRIVER (2797224009) BROKE. THE FRAGMENTED TIP AND THE SCREW WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS WITH LESS THAN A 30-MINUTE SURGICAL DELAY. CONCOMITANT DEVICE: EXP DI POLY SCREW 9X45MM TI (PART#: 179722945, LOT#: RL267374, QUANTITY: 1). THIS REPORT IS FOR ONE (1) DI QUICK CONNECT POLYAXIAL SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882684 ↗
• InjuryNov 26, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019, THE TIP OF THE SCREWDRIVER BROKE OFF, WHEN THE SURGEON WAS INSERTING A 10MM ILIUM BONE SCREW FORCIBLY AGAINST THE ROBUST BONE. AS THE FRAGMENT GOT STUCK IN THE SCREW, THE FRAGMENT HAS BEEN LEFT IN THE PATIENT¿S BODY. SURGERY WAS NOT DELAYED DUE TO REPORTED EVENT. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9378207 ↗
• MalfunctionSep 12, 2019Break; Break

  IT WAS REPORTED THAT THIS WAS A PELVIC FIXATION PROCEDURE PERFORMED ON (B)(6) 2019. THE TIP OF THE SCREWDRIVER (279722400) BECAME STRIPPED AGAINST THE HARD BONE. BECAUSE FRAGMENTS STUCK IN THE SCREW CORE (179722880), THE SCREW WAS ALSO REMOVED AND REPLACED. THE SURGERY WAS COMPLETED LESS THAN A 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: DI POLYAXL SCREW 8 X 80MM (PART#: 179722880, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9003661 ↗
• MalfunctionAug 22, 2019Break; Break

  THE ORIGINAL PLIF PROCEDURE WAS PERFORMED TO STABILIZE L4-5 APPROXIMATELY THREE YEARS AGO. IT WAS REPORTED THAT THIS WAS A REVISION PROCEDURE (PLIF) TREATING SPINAL STENOSIS TO STABILIZE L3-S ON (B)(6) 2019. AFTER INSERTING A SCREW ON THE RIGHT L5, THE SURGEON MOVED ON TO SCREW INSERTION ON THE LEFT L5 WITH THE SCREWDRIVER (279722400). THE SCREW GRADUALLY DID NOT GO DEEPER. REPLACING A RATCHET HANDLE DID NOT CORRECT THE ISSUE. WHEN THE SURGEON DETACHED A QC DRIVER FROM THE UNIT, IT WAS FOUND THAT THE SCREWDRIVER¿S TIP HAD BROKEN OFF AT THE SCREW¿S CORE SECTION. THE SCREW, STUCK WITH THE FRAGMENT, WAS REMOVED FROM THE PATIENT¿S BODY. THE SURGEON COMPLETED THE PROCEDURE WITH A REPLACING SCREW LESS THAN A 30-MINUTE SURGICAL DELAY. NOT MUCH LOAD WAS PUT DURING THE SCREW¿S INSERTION. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8920654 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING SPINAL FIXATION, THE SURGEON INSERTED THE DI SCREW INTO PATIENT¿S LEFT ILIUM AND REPORTED THAT THE DRIVER TIP WAS BROKEN. THE SURGEON REPLACED THE SCREW BECAUSE BROKEN DRIVER TIP WAS ADHERED TO THE SCREW HEAD AND COULD NOT BE REMOVED. THERE WAS A 5 MINUTE SURGICAL DELAY, PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM/CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658270 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT AFTER REPROCESSING OF INSTRUMENT, IT WAS PREPARED FOR SURGERY. WHILE PREPARATION OF THE INSTRUMENTS, A PARTICLE FELL OUT OF THE INSTRUMENT. THE CUSTOMER WANTS TO INVESTIGATE IF IT IS THE METAL ABRASION DUE TO WARING OUT. THE CUSTOMER DOUBTS THAT THE INSTRUMENT COULD REPROCESS PROPERLY IN PROSPECTIVE TO THE SECURER STANDARDS. ALSO THE TIP OF INSTRUMENT BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492515 ↗