EXPEDIUM SFX 289410150Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705034224367), received between Sep 29, 2017 and Jan 16, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (32 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE FAILED THE TORQUE TEST WITH READING 6.2-6.4. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095776 ↗
• MalfunctionDec 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696432 ↗
• MalfunctionApr 2, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PRODUCT FAILED TORQUE TEST DURING INSPECTION AT LOCAL DC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757075 ↗
• MalfunctionDec 9, 2024Calibration Problem; Material Twisted/Bent; Calibration Problem; Material Twisted/Bent

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878881 ↗
• MalfunctionSep 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AUG 14, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176392 ↗
• MalfunctionSep 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE HOSPITAL, IT WAS OBSERVED THAT T-HANDLE, GB153831 WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20175727 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 31,2024 DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT, T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091284 ↗
• MalfunctionAug 28, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON JULY 31, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090898 ↗
• MalfunctionAug 14, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON (B)(6) 2024, IT WAS OBSERVED THAT 65 IN.LBF SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987577 ↗
• MalfunctionAug 14, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986868 ↗
• MalfunctionAug 14, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON (B)(6) 2024, IT WAS OBSERVED THAT THE 65 IN. LBF T-HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986205 ↗
• MalfunctionAug 12, 2024Calibration Problem; Calibration Problem

  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 TORQUE HANDLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968307 ↗
• MalfunctionAug 12, 2024Calibration Problem; Calibration Problem

  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 TORQUE HANDLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962904 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101533 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101530 ↗
• MalfunctionApr 12, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE OLD ITEMS WERE WORN OUT OVER THE TIME DUE TO WEAR AND TEAR OR WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101528 ↗
• MalfunctionFeb 23, 2024Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TORQUE FAILED TORQUE TEST DURING INSPECTION. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768284 ↗
• MalfunctionJan 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT MATERIAL SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS 58.5 ¿ 71.5 IN.LBF. THE TORQUE TESTED HIGH ¿ 73.56 IN.LBF. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476762 ↗
• MalfunctionJan 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR : (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475817 ↗
• MalfunctionJan 9, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475382 ↗
• MalfunctionJul 14, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PLIF WHILE THE FINAL TIGHTENING, TORQUE WAS NOT APPLIED TO THE SFX CROSS CONNECTOR EVEN THOUGH THE SURGEON TIGHTENED WITH CONSIDERABLE FORCE. AFTER MANY ATTEMPTS TO TIGHTEN, THE SET SCREW OF THE SFX CROSS CONNECTOR GOT STRIPPED AND THE SFX CROSS CONNECTOR COULD NOT BE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THE SFX CROSS CONNECTOR IN QUESTION IS A CONSIGNMENT AND THUS NO MAINTENANCE/CHECK IS PERFORMED ON THE VALUES OF TORQUE. THE TIP OF THE SFX TORQUE DRIVER SHAFT MAY HAVE BEEN STRIPPED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM TORQUE HANDLE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326459 ↗
• MalfunctionMay 24, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON MAY 9, 2023, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE MOORESVILLE MD DC, IT WAS OBSERVED THAT THE SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. . THE TORQUE TESTED HIGH . THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED TO THE REPAIR SITE. A REPLACEMENT DEVICE HAS BEEN ORDERED. NO REPLACEMENT PRODUCT IS REQUIRED, AND NO SHIPPING LABEL IS REQUIRED FOR THE PRODUCT RETURN. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991532 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE FINAL STEP OF A SCOLIOSIS SURGERY ON JANUARY 7, 2023, THE SURGEON INPUT THE CROSSLINKS. UPON THE FINAL TIGHTENING OF THE CROSSLINKS NUTS, THE TIP OF THE INSTRUMENT SHAFT ATTACHED TO THE TORQUE LIMITER HANDLE BROKE OFF. THE FRAGMENT OF THE INSTRUMENT SHAFT WAS STUCK INSIDE THE CROSSLINK NUT RECESS. AS THE IMPLANT WOULD BE VERY DIFFICULT TO REMOVE IN ANY FUTURE SURGERY, THE SURGEON DECIDED TO CHANGE THE CROSSLINK FOR THIS PATIENT. BEFORE IMPLANTING IT IN, THE SURGEON TESTED THE FINAL TIGHTENING MECHANISM OUTSIDE OF THE PATIENT'S BODY. THE RESULT WAS THAT THE OTHER INSTRUMENT SHAFT ALSO BROKE OFF AT THE TIP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SFX TORQUE HANDLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381018 ↗
• MalfunctionSep 26, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION FOR THE SCOLIOSIS ON (B)(6) 2022. THE RIGHTMOST OF THE THREE SET SCREWS WAS PROPERLY TORQUED BY THE TORQUE HANDLE IN QUESTION. THE LEFT SET SCREW DID NOT TORQUE OUT, AND THE TIP OF THE DRIVER SHAFT IN QUESTION BROKE. THE BROKEN TIP REMAINED IN THE HOLE OF THE SET SCREW, AND IT WAS IMPOSSIBLE TO REMOVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON GUESSED THAT THE TORQUE HANDLE WAS BROKEN, AND THE SCREW WAS NOT PROPERLY TORQUED OUT, WHICH CAUSED THE BREAKAGE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM TORQUE HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486261 ↗
• MalfunctionJul 12, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, THE SFX TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. TORQUE TESTED LOW (57.5 WITH A DRAWING SPECIFICATION OF 58.5-71.5). THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR A EXPEDIUM SFX CROSS CONNECTOR SYSTEM TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986166 ↗