EXPEDIUM SFX 189401302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034168029), received between Sep 13, 2023 and Dec 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 DECEMBER 7, 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 A2. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18411498 ↗
• 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 A2 5.5 X 28-32MM. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 17735841 ↗

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