EXPEDIUM SFX 189401209Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034167879), received between Oct 31, 2019 and Jun 26, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2023Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE FINAL STEP OF A SCOLIOSIS SURGERY ON (B)(6)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 SFX,5.5,TI, MED, SIZE F9 THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203647 ↗
• MalfunctionMay 6, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SPINAL FUSION FOR THE TREATMENT OF A VERTEBRAL FRACTURE THE CROSS CONNECTORS SCREW STRIPPED DURING FINAL TIGHTENING. ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A LESS THAN THIRTY (30) MINUTE SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR F9 5.5 X 36MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11785758 ↗
• InjuryOct 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RODS FRACTURED AT T12 LEVEL AND SCREWS BROKEN AT L5 LEVEL. REVISION SURGERY TO REPLACE RODS AND EXTEND CONSTRUCT TO S1 AND PELVIS WAS PERFORMED. NO PROBLEMS DURING PROCEDURE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9261703 ↗

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