EXPEDIUM SFX 289410300Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10705034224428), received between Jan 31, 2018 and Jun 26, 2026 — classified as 3 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639860 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639723 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THE DRILL BITS BROKE IN TWO PIECES DURING AN UNKNOWN PROCEDURE. ANOTHER SET WAS OPENED. NO PATIENT CONSEQUENCES. A SURGICAL DELAY OF 3 MINUTES WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25639554 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED WHILE TIGHTENING THE FINAL SCREW, THE TIP OF THE SCREWDRIVER BROKE. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638706 ↗
• MalfunctionApr 8, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE FINAL TIGHTENER WAS BENT AND DID NOT ENGAGE ON THE SET SCREW. AN ALTERNATIVE DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816825 ↗
• MalfunctionNov 26, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PLIF PERFORMED ON (B)(6) 2025. AT THE END OF THE PROCEDURE, WHILE PERFORMING THE FINAL TIGHTENING CROSSLINK WITH THE SCREWDRIVER, THE TORQUE WAS NOT APPLIED PROPERLY AND THE SCREWDRIVER SLIPPED SEVERAL TIMES. SINCE THERE WAS ANOTHER IDENTICAL SCREWDRIVER TIP AVAILABLE, THE SURGEON SWITCHED TO THAT AND WERE ABLE TO USE IT PROPERLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP CHECKED THE TIP OF THE SCREWDRIVER AND CONFIRMED THAT IT HAD BEEN DEFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658719 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 DRIVERS FROM THE EXPEDIUM 4.5 LENGTHENING SET WITH THE DUAL CHAMBER CONNECTER WERE STRIPPED. OTHER AVAILABLE DEVICES WERE USED IN ORDER TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439909 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 DRIVERS FROM THE EXPEDIUM 4.5 LENGTHENING SET WITH THE DUAL CHAMBER CONNECTER WERE STRIPPED. OTHER AVAILABLE DEVICES WERE USED IN ORDER TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22439865 ↗
• MalfunctionJun 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE SURGEON WAS PERFORMING A LENGTHENING OF 4.5 EXPEDIUM AS WELL AS PROXIMAL AND DISTAL ANCHORS WITH EXPEDIUM 5.5 ON (B)(6) 2025. IN THE PROCESS, THE SURGEON STRIPPED THE SHAFT FOR THE FINAL TIGHTENING OF THE CONNECTORS FOR THE 4.5 AND STRIPPED 4 TORQUE DRIVES AS WELL. NO DELAYS WERE OBTAINED; SPARES WERE READILY AVAILABLE. NO IMPACT TO THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195840 ↗
• MalfunctionMay 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TLIF SURGERY, SFX CROSS CONNECTORS WERE USED. THE SFX X20 TORQUE DRIVER SHAFT IN QUESTION, SFX STABILIZER, AND SFX TORQUE HANDLE WERE USED FOR FINAL FASTENING. HOWEVER, THE TIP OF THE SFX X20 TORQUE DRIVER SHAFT IN QUESTION COULD NOT BE ATTACHED SECURELY, AND PROPER FINAL FASTENING COULD NOT BE ACHIEVED. SINCE THE SFX X20 TORQUE DRIVER SHAFT WAS IN A SET OF TWO, THE FINAL FASTENING WAS PERFORMED USING THE OTHER SHAFT. THE SURGEON CHECKED THE TWO TIPS OF THE SFX X20 TORQUE DRIVER SHAFT AND POINTED OUT A DIFFERENCE IN THE SHAPE OF THE TIPS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004043 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE (EXTENSION OF CONSTRUCTION) ON (B)(6) 2025, THE TIP OF THE X20 TORQUE DRIVER SHAFT BROKE WHEN UNSCREWING THE CROSS-LINK SCREWS. ALL FRAGMENTS WERE RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925991 ↗
• MalfunctionJan 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT FINAL TIGHTENER STRIPPED ON FINAL TIGHTENING. THERE WAS NO SURGICAL DELAY DUE TO REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139422 ↗
• MalfunctionDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879117 ↗
• MalfunctionDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879010 ↗
• MalfunctionDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TORQUE HANDLE WAS NOT TIGHTENING AND THE X25 TIGHTENER WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878897 ↗
• MalfunctionDec 9, 2024Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878863 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A PSF FOR A TRAUMA TO THE LUMBAR VERTEBRAE ON (B)(6) 2024. DURING THE SURGERY, THE TIP OF THE SFX X20 TORQUE DRIVER SHAFT GETS STRIPPED WHEN IT IS USED FOR TIGHTENING THE CROSS CONNECTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675849 ↗
• MalfunctionOct 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PART WAS WORN ON THE TIP. NO OTHER INFORMATION WAS PROVIDED. IT WAS UNKNOWN IF THERE WAS PATIENT CONSEQUENCE.

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

  MAUDE report 20515650 ↗
• MalfunctionOct 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DURING A REMOVAL PROCEDURE, ON (B)(6) 2024, THE SFX X20 DRIVER SHAFT WAS USED TO ENGAGE THE CROSSLINK IMPLANT. THE TIP OF DRIVER SHAFT WAS FOUND LEFT IN THE CROSSLINK NUT. NO ADVERSE EFFECT TO THE PROCEDURE NOR PATIENT. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE SFX X20 TORQUE DRIVER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352105 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIP OF A SFX FINAL TIGHTENER IS VISIBLY WORN DOWN AND IS PROVING DIFFICULT TO FINAL TIGHTEN/TORQUE THE IMPLANT. THE DEVICE WAS USED DURING A PROCEDURE AND FINAL TIGHTENED BUT WITH LOTS OF PERSUASION FROM THE SURGEON. THIS REPORT IS FOR A SFX X20 TORQUE DRIVER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181205 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED THAT ON JULY 16, 2024, THE SFX TORQUE HANDLE WAS NOT REACHING ITS TORQUE LIMIT AND WOULDN¿T TORQUE OUT. AS A RESULT, THE TIP OF THE SFX TORQUE SHAFT BROKE OFF IN A A5 CROSS CONNECTOR. THE SALES REP CALLED FOR ANOTHER SFX CROSS CONNECTOR TRAY AND USED A DIFFERENT TORQUE HANDLE AND SHAFT. THERE WAS NO PATIENT INVOLVEMENT AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SFX X20 TORQUE DRIVER SHAFT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962872 ↗
• MalfunctionApr 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON MARCH 1, 2024 THE DRIVERS STRIPPED DURING FINAL TIGHTENING OF SET SCREW. TLIF INSERTERS BENT FROM OVER TIGHTENING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE SFX X20 TORQUE DRIVER SHAFT. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142375 ↗
• MalfunctionApr 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DETERMINED THE DEVICES WERE WORN OUT DUE TO WEAR AND TEAR OR WERE BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SFX X20 TORQUE DRIVER SHAFT FOR (B)(4). COMPLIANT IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117835 ↗
• MalfunctionApr 16, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DETERMINED THE DEVICES WERE WORN OUT DUE TO WEAR AND TEAR OR WERE BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE SFX X20 TORQUE DRIVER SHAFT FOR (B)(4). COMPLIANT IS LINKED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117663 ↗
• MalfunctionApr 15, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE OLD ITEMS WERE WORN OUT OVER TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE SFX X20 TORQUE DRIVER SHAFT THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105253 ↗