EXPEDIUM 279712150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034198835), received between Dec 8, 2020 and Dec 7, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING A PROCEDURE ON (B)(6) 2023, AN EXPEDIUM SI SCREW DRIVER WAS DAMAGED. IT WAS NOT POSSIBLE TO LOAD A SCREW ONTO THIS DRIVER AS THE THREAD WAS BENT. THIS REPORT IS FOR A DRIVER SHAFT FOR SI SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287582 ↗
• MalfunctionNov 29, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 7, 2023 AFTER EXISTING EXPEDIUM DI PSF REMOVAL PROCEDURE IT WAS NOTICED THAT THE TORQUE HANDLE AND T-HANDLE COULD NOT BE DISCONNECTED FROM THE X25 TORQUE DRIVER SHAFT, AND T20 SCREW DRIVER SHAFT WITHOUT A GREAT DEAL OF FORCE AND MANIPULATION. THEY WERE SUBSEQUENTLY INSPECTED AND BURRING WAS PRESENT ON THE INSERTION END OF THESE SHAFTS. THE POLYAXIAL SCREW DRIVER ALSO HAS VERY VISIBLE BURRING ALONG THE THREAD. THERE WAS NO PATIENT IMPACT. IT WAS FURTHER REPORTED THAT THERE WAS NO ISSUE WITH DEPUY SYNTHES IMPLANTS. SURGEON DECIDED TO USE COMPETITOR PRODUCT SO HAD TO REMOVE DEPUY SYNTHES IMPLANTS. THIS REPORT IS FOR ONE (1) DRIVER SHAFT FOR SI SCREWS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233788 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHEN REPOSITIONING THE SCREW, THE HEX AT THE TIP OF THE SCREEN DRIVER APPEARED TO BE ROUNDED, AND WOULD NOT TURN THE SCREW TO BACK IT OUT. THE REGULAR 5.5 SCREW DRIVER WAS USED INSTEAD AND THE SCREW WAS REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM DRIVER SHAFT SI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765723 ↗
• MalfunctionMay 17, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON AN UNKNOWN DATE. THE SCREW DRIVER SHAFT WAS BURRED, AND IT WOULD NOT ENGAGE WITH THE SCREW HEAD WHEN TRYING TO ENGAGE. A SECOND DRIVER FROM THE SET WAS USED INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DRIVER SHAFT FOR SI SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949711 ↗
• InjuryNov 9, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TIP OF THE EXPEDIUM SCREWDRIVER SHAFT (279712150) SHEARED OFF WHILE INSERTING THE PEDICLE SCREW. THE SHEARED OFF TIP REMAINED IN THE SCREW SHANK RECESS. STEPS HAD TO BE TAKEN TO REMOVE THE SCREW. THE SURGERY WAS DELAYED BY 150 MINUTES AS A RESULT OF THIS EVENT. THE BROKEN SCREW REMOVAL SETS WERE SENT TO THE OR, SOME OF WHICH HAD TO BE STERILIZED BEFORE BEING ABLE TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND FRAGMENTS WERE EASILY REMOVED WITHOUT FURTHER INTERVENTION. THERE WAS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM DRIVER SHAFT SI. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 15760668 ↗
• InjuryDec 8, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN XLIF (EXTREME LATERAL INTERBODY FUSION) AT L4/5. WHEN SURGEON REMOVING THE SCREWS AT S., THE SCREWHEAD CAME OFF. SURGEON LEFT THE SHAFT IN THE PATIENT. ALL FRAGMENTS WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED WITH 30 MINUTES DELAY. THE PATIENT IS NOT SCHEDULED TO UNDERGO ANOTHER PROCEDURE. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) DEPTH GAUGE FOR SMALL SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10970055 ↗