EXPEDIUM VERSE 299704152Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10705034477138), received between Apr 8, 2020 and Jan 23, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (70 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE POLYDRIVER HANDLE WILL NO LONGER ENGAGE WITH SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159604 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A VERSE POLY DRIVER SLEEVE WAS RELEASING THE INNER SHAFT ON LOADING THE SCREW. THIS PIECE WILL NOT EVEN CONNECT WITH THE LIP/NOTCH IN THE INNER SHAFT AND SLIDES EASILY UP AND DOWN. THIS WAS A NEW DEVICE, USED FOR THE FIRST TIME. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742925 ↗
• MalfunctionJul 16, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT WHEN INSERTING SCREWS THE SLEEVE KEPT STICKING AND WAS DIFFICULT TO DISENGAGE. THERE IS A SECOND SLEEVE ON THE SET AND WAS USED TO CONTINUE INSERTING THE SCREWS. AT THE END OF THE CASE WHEN IT CAME TO FINAL TIGHTENING THE CORRECTION KEYS, THE FINAL TIGHTENING DRIVER KEPT STRIPPING AND NOT TIGHTENING, ANOTHER SET WAS OPENED TO USE A DRIVER THAT DIDN¿T STRIP. CURRENTLY, THERE ARE NO KNOWN ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WAS A MINIMAL DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520249 ↗
• MalfunctionJun 11, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A SPINAL POSTERIOR FUSION FOR OPLL ON (B)(6) 2025. WHEN THE SCREW WAS ATTACHED IN THE VERSE DRIVER, THE SCREW CAME OFF FROM THE SHAFT WHILE STILL ATTACHED TO THE HANDLE. AS THE SCREW AND HANDLE COULD NOT BE REMOVED, A NEW SCREW WAS ATTACHED TO A SPARE SCREWDRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE HANDLE AND SCREW WERE REMOVED USING AMERICAN PLIERS. WHEN THE SCREW WAS ATTACHED, IT WAS POSSIBLE THAT THE THREADS OF THE HANDLE HAD BEEN DAMAGED BECAUSE IT HAD BEEN TIGHTENED WITH EXCESSIVE FORCE, BUT THE EXACT REASON WHY IT COULD NOT BE REMOVED WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186214 ↗
• MalfunctionApr 3, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE BUTTON OF THE POLYDRIVER BODY GETS STUCK CAUSING THE SHAFT (SCREWDRIVER) TO FALL OUT. THE SLEEVE AND THE BODY STAY IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767458 ↗
• MalfunctionFeb 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE IN 2025. THE VERSE POLYDRIVER HANDLE WOULD NOT RETAIN THE SCREWDRIVER SHAFT. ANOTHER INSTRUMENT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379183 ↗
• MalfunctionJan 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A EXAPEDIUM VERSE SURGERY THE SCRUB NURSE NOTED THAT VERSE SCREWDRIVER SHAFT AND VERSE POLYDRIVER HANDLE DISENGAGES FROM EACH OTHER DURING TIGHTENING OF THE HANDLE TO THE SCREWHEAD. THE SCREW WOULD NOT STAY CONNECTED TO THE SHAFT AND IT COULD NOT BE INSERTED CORRECTLY. THE CAUSE OF THE DISENGAGEMENT SEEMS TO BE A MALFUNCTION OF THE CLOSURE MECHANISM OF THE POLYDRIVER HANDLE. A SECOND INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148802 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A PROBLEM WITH ACCURACY INVOLVING THE ENTIRE SCREWDRIVER WITH O-ARM NAVIGATION WHEN USING THE LONG ARRAY. WHAT THE NAVIGATION SYSTEM SEES IS NOT WHAT WAS OBSERVE IN THE BODY. RE-CALIBRATION WAS DONE TWICE, AND THE SPHERES WERE ALSO CHECKED. DESPITE THIS, ACCURACY REMAINED AN ISSUE. WHEN THE SCREWDRIVER WAS CHANGED TO ANOTHER ONE, IT WORKED. SURGERY WAS DELAYED 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533407 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH ACCURACY INVOLVING THE ENTIRE SCREWDRIVER WITH O-ARM NAVIGATION WHEN USING THE LONG ARRAY. WHAT THE NAVIGATION SYSTEM SEES IS NOT WHAT WE OBSERVE IN THE BODY. RE-CALIBRATION WAS DONE TWICE, AND THE SPHERES WERE ALSO CHECKED. DESPITE THIS, ACCURACY REMAINED AN ISSUE. WE THEN CHANGED THE SCREWDRIVER TO ANOTHER ONE, AND IT WORKED. IT WAS UNCLEAR IF THE PROBLEM WAS COMING FROM THE SCREWDRIVER, THE ARRAY, OR THE ADAPTER. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT, AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531797 ↗
• MalfunctionOct 2, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DURING THE SURGERY IT IS EVIDENT THAT THE HANDLE OF THE POLYAXIAL SCREWDRIVER DOES NOT HOLD THE SCREWDRIVER PIECE WELL SINCE THIS PIECE IS LOOSE AND DOES NOT RETAIN ITS ASSEMBLY FOR ITS OPERATION. ANOTHER HANDLE WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES. AT THE END, REPORT IS LEFT IN THE CASE REPORT AND BY THIS MEANS; THE PIECE THAT PRESENTED THE NOVELTY IS MARKED AND LEFT INSIDE THE EQUIPMENT FOR EASY IDENTIFICATION AND CHANGE OR REPAIR. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THIS REPORT INVOLVES ONE VERSE POLY DRIVER, HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352748 ↗
• MalfunctionSep 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT NO DELAYS IN SURGERY OCCURRED. THE PROCEDURE WAS PERFORMED WITHOUT ALTERATIONS IN SURGICAL TIMES. THE SURGERY WAS PERFORMED SUCCESSFULLY WITHOUT AFFECTING THE PATIENT. NO FURTHER SURGICAL OR MEDICAL INTERVENTION WAS NECESSARY AND NO BROKEN FRAGMENTS WERE LEFT ON THE PATIENT; THE PART THAT FAILED DURING THE PROCEDURE IS A POLYAXIAL SCREWDRIVER THAT DOES NOT GRIP THE SCREW PROPERLY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292705 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE IN (B)(6) 2024, THE RELEASE BUTTONS FOR POLY DRIVER WAS STUCK AND UNABLE TO RELEASE THE DRIVERS. DRIVERS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268037 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE IN (B)(6) 2024, THE RELEASE BUTTONS FOR POLY DRIVER WAS STUCK AND UNABLE TO RELEASE THE DRIVERS. DRIVERS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268032 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE IN (B)(6) 2024, THE RELEASE BUTTONS FOR POLY DRIVER WAS STUCK AND UNABLE TO RELEASE THE DRIVERS. DRIVERS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268021 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE IN (B)(6) 2024, THE RELEASE BUTTONS FOR POLY DRIVER WAS STUCK AND UNABLE TO RELEASE THE DRIVERS. DRIVERS STRIPPED. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268019 ↗
• MalfunctionSep 19, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO FRAGMENTS WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258937 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE VERSE SCREWDRIVER SLEEVE BROKE DURING A CASE. THE LOCKING MECHANISM THAT KEEPS THE SLEEVE ON THE DRIVER BROKE DUE TO OVER TIGHTENING THE DRIVER TO SCREW AN IMPLANT. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258311 ↗
• MalfunctionAug 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER FOR VERSE KEPT DISMANTLING WHEN A SCREW WAS LOADED. MAKING THE SCREWDRIVER UN-USABLE. ANOTHER SCREWDRIVER TRAY WAS OPENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009127 ↗
• MalfunctionMay 16, 2024Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THE SCRUB NURSE COULD NOT ASSEMBLE THE SCREWDRIVER TOGETHER. THE VERSE POLYDRIVER BODY DID NOT ENGAGE WITH THE VERSE POLYAXIAL SCREW DRIVER SHAFT . SINCE THEY ARE 2 OF EACH IN THE KIT, THE SURGERY WAS NOT IMPACTED. THE EXTENSION OF THE CASE WAS MINIMAL. THE SURGERY WAS A SUCCESS IN THE END. THE PATIENT WAS NOT IMPACTED. THIS REPORT INVOLVES ONE (1) EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335786 ↗
• MalfunctionApr 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON MARCH 22, 2024, THAT VERSE POLYDRIVER SHAFT WITH (B)(6) KEEPS ON DETACHING INTO THE POLYDRIVER HANDLE WITH (B)(6) EVERY TIME SCRUB PERSONNEL WAS LOADING A PEDICLE SCREW. NO ISSUES RELATED TO THE PEDICLE SCREWS. TRIED THE OTHER HANDLE IN THE SET AND IT WORKS FINE. THERE WAS NO SURGICAL DELAY. SURGICAL . THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, HANDLE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054288 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 08-MARCH-2024, THE POLY DRIVER X-25 WAS NOT FIXED IN THE POLYDRIVER HANDLE AS INTENDED. THE DRIVER COULD BE PUSHED OUT WITHOUT ACTIVATING THE BUTTON ON THE HANDLE. THERE WAS NO ADVERSE PATIENT IMPACT, THE ISSUE WAS DISCOVERED PREOPERATIVELY. ANOTHER INSTRUMENT WAS USED FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL DRIVER, HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963565 ↗
• MalfunctionAug 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN EXPEDIUM VERSE PROCEDURE ON (B)(6) 2023, THE SURGEON FOUND THAT THE HANDLE FOR THE EXPEDIUM VERSE DRIVER WAS NOT PROPERLY HOLDING THE SCREWS AND THAT THE TAB BREAKER WAS MALFUNCTIONING. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A VERSE POLY DRIVER, HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503060 ↗
• MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, HANDLE. THIS IS REPORT 8 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109900 ↗
• MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, HANDLE THIS IS REPORT 7 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109205 ↗
• MalfunctionJun 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PART NUMBERS IN THE PHOTOS ARE THE PRODUCTION REFERENCES BUT AT SOME POINT WERE MODIFIED TO WHAT CAN BE SEEN HERE IN THE DECK. THERE WERE 2 OF THE ¿¿ WITH TAB¿? ASSEMBLIES AND 1 OF THE ¿¿NO-TAB ASSEMBLY WAS REMOVED FROM A HOSPITAL UPON IDENTIFICATION. THIS REPORT IS FOR ONE (1) VERSE POLY DRIVER, HANDLE THIS IS REPORT 6 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108758 ↗