EXPEDIUM 279734000NRecalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10705034388410), received between Aug 4, 2017 and Jul 8, 2025 — classified as 12 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Break” (78 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO DRIVERS STRIPPED AND BROKE DURING SURGERY. NEW DRIVERS HAD TO BE ACQUIRED IN CENTRAL PROCESSING. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439790 ↗
• MalfunctionJul 8, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO DRIVERS STRIPPED AND BROKE DURING SURGERY. NEW DRIVERS HAD TO BE ACQUIRED IN CENTRAL PROCESSING. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439776 ↗
• MalfunctionJun 18, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SURGEON BROKE THE TIP OFF OF AN EXPEDIUM NAVIGATION SCREWDRIVER WHILE INSERTING A SCREW. THE TIP OF THE DRIVER BROKE OFF FLUSH INSIDE THE SCREW. THE SURGEON WAS NOT ABLE TO REMOVE THE TIP OF THE DRIVER AND NOT ABLE TO REMOVE THE SCREW. SINCE THE TIP OF THE DRIVER WAS FLUSH INSIDE THE DRIVE MECHANISM OF THE SCREW THE SURGEON WAS ABLE TO INSERT THE ROD WITH NO TROUBLE. THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF 5 MINS. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22287199 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DRIVER TIPS BROKE DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469025 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE DRIVER TIPS BROKE DURING SCREW INSERTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468998 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW DRIVERS BROKE IN THE FRONT WHILE PUTTING THE SCREWS IN AND COULD NOT BE USED ANYMORE. SCREWDRIVERS WERE CHANGED TO ANOTHER SCREWDRIVERS. THERE WAS A 20 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306025 ↗
• MalfunctionOct 31, 2024Break; Break

  TIP OF EXPEDIUM BRAINLAB NAVIGATION SCREW DRIVER BROKE OFF INSERTING 8MM EXPEDIUM SCREW. IT WAS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IT WAS ALSO UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577625 ↗
• MalfunctionOct 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO OTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401099 ↗
• MalfunctionSep 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING SCREW INSERTION, THE SURGEON ENCOUNTERED SCLEROTIC BONE. THEY ATTACHED T-HANDLE TO THE DRIVER FOR MORE TORQUE; NAVIGATED SCREWDRIVER HEAD BROKE OFF WITHIN THE IMPLANTED SCREW TWICE. THE FRAGMENTS WERE LEFT IN THE PATIENT AS THEY WERE STUCK IN THE SCREW HEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 5.5 VIPER UNIV POLY DRIVER.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207523 ↗
• MalfunctionSep 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING SCREW INSERTION, THE SURGEON ENCOUNTERED SCLEROTIC BONE. THEY ATTACHED T-HANDLE TO THE DRIVER FOR MORE TORQUE; NAVIGATED SCREWDRIVER HEAD BROKE OFF WITHIN THE IMPLANTED SCREW TWICE. THE FRAGMENTS WERE LEFT IN THE PATIENT AS THEY WERE STUCK IN THE SCREW HEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 5.5 VIPER UNIV POLY DRIVER.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206305 ↗
• MalfunctionSep 9, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE TIP OF THE NAVIGATED SCREWDRIVER BROKE OFF WITHIN THE SCREW HEAD. IT WAS IMPOSSIBLE TO RECOVER THE BROKEN PIECE AND IT WAS DECIDED TO LEAVE IT WITHIN THE SCREW HEAD AS IT WAS NOT PREVENTING PLACEMENT OF THE ROD AND LOCK THE SETSCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 5.5 VIPER UNIV POLY DRIVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20170091 ↗
• MalfunctionJul 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF SCREWDRIVER BROKE OFF DURING INSERTION OF SCREW IN PATIENT. THE TIP OF SCREWDRIVER WAS FIXED IN SCREW AND COULD NOT BE REMOVED. THERE WERE NO CONSEQUENCE FOR PATIENT. THE SURGERY IF DONE AS PLANNED. POSSIBLE TO PLACE ROD AND SET SCREW AND FINISH INSTRUMENTATION AS PLANNED THIS REPORT INVOLVES ONE (1) UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794943 ↗
• MalfunctionJun 4, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAY 7, 2024, AFTER INSERTING THE SCREW WITH THE DRIVER, THE DRIVER WOULD NOT DISENGAGE FROM THE SCREW. WHEN HOLDING THE DRIVER STILL AND SPINNING THE SLEEVE COUNTER CLOCKWISE, THE DRIVER WOULD NOT RELEASE THE SCREW AND INSTEAD CAUSED THE SCREW ITSELF TO BACK OUT. A KOCHER WAS USED TO HOLD THE SHAFT STILL AND BACK THE HOLDING SLEEVE OFF. THE PROCEDURE WAS ABLE TO BE FINISHED WITH THE SECONDARY. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458045 ↗
• MalfunctionJun 4, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON MAY 7, 2024, AFTER INSERTING THE SCREW WITH THE DRIVER, THE DRIVER WOULD NOT DISENGAGE FROM THE SCREW. WHEN HOLDING THE DRIVER STILL AND SPINNING THE SLEEVE COUNTER CLOCKWISE, THE DRIVER WOULD NOT RELEASE THE SCREW AND INSTEAD CAUSED THE SCREW ITSELF TO BACK OUT. A KOCHER WAS USED TO HOLD THE SHAFT STILL AND BACK THE HOLDING SLEEVE OFF. THE PROCEDURE WAS ABLE TO BE FINISHED WITH THE SECONDARY. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458023 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE IN 2024. THE TWO DRIVERS SNAPPED OFF FROM THE TIP, DURING THE CASE. THERE WERE NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754095 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2023, A SCREWDRIVER AND SCREW HEAD BROKE. THE BROKEN SCREWDRIVER PIECE WAS TAKEN OUT OF THE PATIENT. THE TULIP OF THE SCREW THAT BROKE OFF WAS TAKEN OUT. THE SHAFT OF THE SCREW REMAINED IN THE PATIENT. THERE WAS A REPORTED ONE HOUR OF SURGICAL DELAY. THIS REPORT IS FOR ONE 5.5 VIPER UNIV POLY DRIVER FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18562358 ↗
• MalfunctionDec 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT WHILE DISASSEMBLING THE INSTRUMENT TO PREPARE FOR STERILIZATION, PARTICLES FROM THE PREVIOUS SURGERY WERE FOUND IN THE INSTRUMENT. THE HOSPITAL GOT THE INSTRUMENT FROM ANOTHER HOSPITAL FOR A SURGERY. PARTICLES WERE FOUND BEFORE STERILIZATION, AND NO PATIENT WAS INVOLVED. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411677 ↗
• MalfunctionSep 21, 2023Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE EXPEDIUM NAVIGATED SCREWDRIVER BROKE IN THE SCREWHEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FORTY-FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794330 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THEN DRIVER BROKE. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491412 ↗
• MalfunctionJun 13, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE INITIAL SURGERY (L5/S) USING SCREWS OF EXPEDIUM WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2023, A PLIF (L2/3/4) USING A COMPETITOR¿S PRODUCTS WAS PERFORMED. AT FIRST, REMOVAL OF THE SCREWS OF EXPEDIUM AT L5/S WERE NOT PLANNED IN THE PLIF. BUT THE SURGEON CHANGED THE PLAN AND CONSULTED WITH THE SALES REP. THE SALES REP SUGGESTED TO USE THE SCREWDRIVERS FOR EXPEDIUM. THE SURGEON COULD REMOVE THE SCREW AT L5 BUT COULD NOT REMOVE THE SCREW AT S PARTLY BECAUSE THE BONE HAD HARDENED. DURING REMOVAL OF THE SCREW AT S, TWO (2) SCREWDRIVERS BROKE. THE SCREW AT S WAS DETERMINED TO BE REMAINED IN THE BODY BECAUSE IT WAS NOT PLANNED TO BE REMOVED ORIGINALLY. THE PLIF WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115996 ↗
• MalfunctionJun 13, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS, AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED, THAT THE INITIAL SURGERY (L5/S) USING SCREWS OF EXPEDIUM WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2023, A PLIF (L2/3/4) USING A COMPETITOR¿S PRODUCTS WAS PERFORMED. AT FIRST, REMOVAL OF THE SCREWS OF EXPEDIUM AT L5/S WERE NOT PLANNED IN THE PLIF. BUT THE SURGEON CHANGED THE PLAN AND CONSULTED WITH THE SALES REP. THE SALES REP SUGGESTED TO USE THE SCREWDRIVERS FOR EXPEDIUM. THE SURGEON COULD REMOVE THE SCREW AT L5, BUT COULD NOT REMOVE THE SCREW AT S PARTLY, BECAUSE THE BONE HAD HARDENED. DURING REMOVAL OF THE SCREW AT S. TWO (2) SCREWDRIVERS BROKE. THE SCREW AT S WAS DETERMINED, TO BE REMAINED IN THE BODY, BECAUSE IT WAS NOT PLANNED TO BE REMOVED ORIGINALLY. THE PLIF WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115986 ↗
• InjuryMar 30, 2023Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING EXPEDIUM NAVIGATED DRIVER (297934000) WITH EXPEDIUM T HANDLE AND INSERTING A EXPEDIUM 8.0 X 50MM POLYAXIAL SCREW. A LOUD CRACK WAS HEARD, AND WHEN THE SURGEN BACKED THE DRIVER OUT OF THE IMPLANTED SCREW, THE DISTAL TIP OF THE DRIVER WAS MISSING AND HAD ¿COLD WELDED¿ TO THE INSIDE OF THE IMPLANTED POLY HEAD. THE DISTAL TIP FRAGMENT WAS NOT ABLE TO BE REMOVED FROM THE POLY SCREW HEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THIS REPORT IS FOR A UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16643621 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON WAS DOING A REVISION AND WHEN HE WENT TO REMOVE THE OLD SCREWS AND RE-IMPLANTING THE NEW SCREWS THE TIP OF THE DRIVERS BROKEN OFF. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117565 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON WAS DOING A REVISION AND WHEN HE WENT TO REMOVE THE OLD SCREWS AND RE-IMPLANTING THE NEW SCREWS THE TIP OF THE DRIVERS BROKEN OFF. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 5.5 VIPER UNIV POLY DRIVER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117535 ↗
• MalfunctionDec 6, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS USING THE IGS SCREW DRIVER IN COMBINATION WITH THE STEALTH ADAPTOR AND NAVIGATION AT TIME OF THE INCIDENT. HE USED A 10X100MM EXPEDIUM SCREW IN THE S2AI REGION AND THE TORQUE FORCE BROKE THE TIP OF THE SCREWDRIVER IN THE SCREW SHAFT, WHICH MEANT THAT THERE WAS NO WAY TO RE-ENGAGE ANOTHER SCREW DRIVER TO TURN THE SCREW ALL THE WAY DOWN. THE SURGEON CALIBRATED ANOTHER SCREWDRIVER AS THERE WERE TWO ON THE SET TO PUT IN A 10X90MM SCREW ON THE SAME LEVEL BUT ON THE OPPOSITE SIDE, AND THE SAME THING HAPPENED. LUCKILY THE SCREWS WERE FAR ENOUGH DOWN SO THAT THE SURGEON COULD ACCEPT THE POST-OP X-RAY, AND THE OUTCOME FOR THE PATIENT WAS GOOD. THERE WAS A SLIGHT DELAY IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925792 ↗