EXPEDIUM SFX 189401303Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034168036), received between Jul 10, 2023 and Sep 9, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K062196, K111136, K142460); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION FOR A VERTEBRAL BURST FRACTURE ON (B)(6) 2025. USING THE SFX, THE SURGEON ATTEMPTED FINAL TIGHTENING ACCORDING TO THE PROCEDURE MANUAL, BUT THE DEVICE STRIPPED, AND THE SURGEON WAS UNABLE TO COMPLETE THE FINAL TIGHTENING OF THE SCREW. THE HOSPITAL HAD ANOTHER PRODUCT OF THE SAME SPECIFICATIONS AS THE SFX IN QUESTION, SO THE SURGEON USED THAT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON HAVE EXPERIENCED A SIMILAR PHENOMENON WITH THE SFX IN THE PAST, SO THEY PERFORMED THE FINAL TIGHTENING OPERATION WITH GREAT CARE, BUT THIS TIME, THE BEING STRIPPED OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008543 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A3 5.5 X 32-37MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18491327 ↗
• MalfunctionDec 28, 2023Mechanical Problem; Material Twisted/Bent; Mechanical Problem; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN KOREA, SOUTH AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT IN THE PROCESS OF TIGHTENING THE SOCKET NUT, WEAR OCCURRED, PREVENTING THE NEXT STEP FROM BEING CARRIED OUT. IT IS UNKNOWN IF THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IS UNKNOW IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SFX,5.5,TI, LAT, SIZE A3. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18411493 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A PSF (POSTERIOR SPINAL FUSION) AT T9-L1 WAS PERFORMED ON (B)(6) 2014. AFTER SURGERY, A PRESSURE ULCER WAS OBSERVED AT THE UPPER END OF T9. IC WAS HELD BETWEEN THE SURGEON AND THE PATIENT TO CONFIRM WHETHER TO REMOVE ONLY THE ROD AT THE AFFECTED SITE, OR TO REMOVE ALL THE IMPLANTS. IT WAS DECIDED TO REMOVE ALL IMPLANTS. THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2023. BONE UNION IS COMPLETE. ALL IMPLANTS WERE REMOVED WITHOUT ANY PROBLEMS, AND THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A3 5.5 X 32-37MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735758 ↗
• MalfunctionJul 10, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A SPINAL FUSION (T8-L2) FOR A VERTEBRAL BODY FRACTURE. AFTER TEMPORARY FIXATION OF THE SFX CROSS CONNECTOR WAS COMPLETED, THE SURGEON ATTEMPTED FINAL TIGHTENING WITH A SFX TORQUE DRIVER SHAFT. HOWEVER, THE SHAFT GOT STRIPPED MULTIPLE TIMES WHILE ENGAGED WITH THE SET SCREW OF THE SFX CROSS CONNECTOR. THE FINAL TIGHTENING COULD NOT BE COMPLETED, SO THE SURGEON SWITCHED FROM THE SFX CROSS CONNECTOR TO ANOTHER STANDARD SFX F9. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A3 5.5 X 32-37MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289907 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062196, K111136, K142460. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467