EXPEDIUM 279712400Recalls & reported problems

Summary

The FDA's MAUDE database contains 551 adverse event reports that list this exact device (DI 10705034198897), received between Jul 7, 2017 and Sep 30, 2026 — classified as 53 injuries, 498 malfunctions.

The most frequently reported specific device problem is “Break” (336 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 551 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported the screwdriver tip broke off on an unknown date. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944659 ↗
• MalfunctionMay 4, 2026Device-Device Incompatibility

  DURING A PROCEDURE, THE SCREWDRIVER WAS NOT ENGAGING PROPERLY TO THE SCREW AND WAS COMING LOOSE WHEN INSERTING THE SCREW. THE REMAINING SCREWDRIVER IN THE SET WAS USED INSTEAD. NO IMPACT OR HARM OCCURRED TO THE PATIENT. THERE WAS A ONE MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 25069044 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREWDRIVER TIPS HAVE BEEN WORN OUT MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884295 ↗
• MalfunctionApr 15, 2026Material Twisted/Bent

  IT WAS REPORTED MULTIPLE SCREWDRIVER TIPS HAVE BEEN WORN OUT, MAKING IT DIFFICULT TO USE. NO PATIENT IMPACTED. NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883445 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT THIS WAS A FLIF (L4) FOR AN ADULT SPINAL DEFORMITY ON (B)(6) 2026. DURING THE SCREW INSERTION, THERE WAS A LOT OF RESISTANCE BECAUSE THE BONE WAS QUITE SCLEROTIC WITHIN ALSO THE VERTEBRAL BODY AND PEDICLE, SO INSERTION NEEDED A LOT OF FORCE. SO, THE SMALL DIAMETER TAP WAS USED FIRST, AND THERE WAS STRONG RESISTANCE DURING 7×4MM SCREW INSERTION AFTER 6MM TAP WAS USED FINALLY, AND THE TIP OF THE DRIVER BROKE, AND THE TIP OF THE DRIVER WAS STUCK ON THE DEEP INSIDE OF SCREW HEAD. THE TIP OF THE DRIVER COULD NOT BE REMOVED, SO THE NEW SCREW WAS INSERTED AFTER THE SCREW IN QUESTION WAS REMOVED. SUBSEQUENT SCREW INSERTION WAS PERFORMED USING ANOTHER DRIVER OF THE SAME TYPE REMAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845154 ↗
• MalfunctionMar 11, 2026Mechanical Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER WAS WORN AND DID NOT PROVIDE SCREW TIGHTENING. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570400 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THE DEVICES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376175 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THE DEVICES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376136 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION FOR KYPHOSIS A SNAPPING SOUND WAS HEARD WHEN INSERTING THE SCREW. WHEN THE SCREWDRIVER WAS REMOVED FROM THE SCREW, THE TIP OF THE SCREWDRIVER BROKE OFF AND BECAME LODGED DEEP INSIDE THE SCREW HEAD. THE SURGEON TRIED TO REMOVE THE BROKEN PART, BUT IT DID NOT COME OUT, SO THE SURGEON REMOVED THE SCREW TOGETHER. A REPLACEMENT SCREW WAS INSERTED USING A DIFFERENT SCREWDRIVER, AND THE SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194960 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE DURING THE INSERTION OF A VERY LARGE 11MM DIAMETER SCREW. SURGERY WAS NOT IMPACTED SINCE THE MODULE HAD TWO OF THE SAME ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573664 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A VERY COMPLICATED PATIENT HAD VERY HARD BONE THAT BROKE SEVERAL INSTRUMENTS DURING THE PROCEDURE. THERE WERE NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453703 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A VERY COMPLICATED PATIENT HAD VERY HARD BONE THAT BROKE SEVERAL INSTRUMENTS DURING THE PROCEDURE. THERE WERE NO SURGERY DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452900 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRODUCT IS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290950 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRODUCT IS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290268 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE, THE DRIVERS WERE BROKEN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017687 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE; THE DRIVERS WERE BROKEN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017625 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON WAS PERFORMING A T10 TO PELVIS SURGERY ON A PATIENT WITH VERY HARD BONE. DURING THE PROCESS, THE EXPEDIUM PROBE AND FOUR POLYAXIAL SCREWDRIVERS GOT STRIPPED AT THE DISTAL END TIP. NO CONSEQUENCES WERE EXPERIENCED FROM A PATIENT'S PERSPECTIVE AND THERE WERE NO DELAYS AS SPARES WERE READILY AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459926 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON WAS PERFORMING A T10 TO PELVIS SURGERY ON A PATIENT WITH VERY HARD BONE. DURING THE PROCESS, THE EXPEDIUM PROBE AND FOUR POLYAXIAL SCREWDRIVERS GOT STRIPPED AT THE DISTAL END TIP. NO CONSEQUENCES WERE EXPERIENCED FROM A PATIENT'S PERSPECTIVE AND THERE WERE NO DELAYS AS SPARES WERE READILY AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459925 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON WAS PERFORMING A T10 TO PELVIS SURGERY ON A PATIENT WITH VERY HARD BONE. DURING THE PROCESS, THE EXPEDIUM PROBE AND FOUR POLYAXIAL SCREWDRIVERS GOT STRIPPED AT THE DISTAL END TIP. NO CONSEQUENCES WERE EXPERIENCED FROM A PATIENT'S PERSPECTIVE AND THERE WERE NO DELAYS AS SPARES WERE READILY AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459921 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  THE SURGEON WAS PERFORMING A T10 TO PELVIS SURGERY ON A PATIENT WITH VERY HARD BONE. DURING THE PROCESS, THE EXPEDIUM PROBE AND FOUR POLYAXIAL SCREWDRIVERS GOT STRIPPED AT THE DISTAL END TIP. NO CONSEQUENCES WERE EXPERIENCED FROM A PATIENT'S PERSPECTIVE AND THERE WERE NO DELAYS AS SPARES WERE READILY AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459919 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE TORX OF THE EXPEDIUM SCREWDRIVER IS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330607 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT ONE OF THE POLYAXIAL DRIVER TIPS DOES NOT SIT FLUSH ON THE SCREW HEAD CAUSING THE SCREW'S THREADS TO BE LOOSE WHILE BEING IMPLANTED. TWO OF THE POLYAXIAL DRIVER TIPS BROKE OFF AND THE INSTRUMENT WAS NOT USABLE. THERE WAS NO SURGICAL DELAY. THE BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318593 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT ONE OF THE POLYAXIAL DRIVER TIPS DOES NOT SIT FLUSH ON THE SCREW HEAD CAUSING THE SCREW'S THREADS TO BE LOOSE WHILE BEING IMPLANTED. TWO OF THE POLYAXIAL DRIVER TIPS BROKE OFF AND THE INSTRUMENT WAS NOT USABLE. THERE WAS NO SURGICAL DELAY. THE BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318569 ↗
• MalfunctionJun 24, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ONE OF THE POLYAXIAL DRIVER TIPS DOES NOT SIT FLUSH ON THE SCREW HEAD CAUSING THE SCREW'S THREADS TO BE LOOSE WHILE BEING IMPLANTED. TWO OF THE POLYAXIAL DRIVER TIPS BROKE OFF AND THE INSTRUMENT WAS NOT USABLE. THERE WAS NO SURGICAL DELAY. THE BROKEN FRAGMENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318485 ↗
• MalfunctionJun 18, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE SCREWDRIVER TIP OFF OF THE POLYAXIAL SCREWDRIVER BROKE OFF DUE TO EXCESSIVE FORCE FROM THE SURGEON. SURGERY NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22284257 ↗