EXPEDIUM SFX 189401404Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034168111), received between Jan 9, 2020 and Aug 21, 2023 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF FOR SCOLIOSIS ON (B)(6) 2023. DURING SURGERY, SET SCREWS OF THE SFX GOT STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SFX,5.5,TI, MED, SIZE A4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585836 ↗
• MalfunctionJun 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AT THE DISTRIBUTOR WAREHOUSE (B)(6), 2023, THE IMPLANT'S SET SCREW (CENTER) WOULDN'T TIGHTEN AND RELEASE. THIS REPORT IS FOR A SFX,5.5,TI, MED, SIZE A4. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050081 ↗
• MalfunctionDec 7, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A POSTERIOR SPINAL FUSION FOR ASD, WHILE FINAL TIGHTENING THE SFX SET SCREW IN QUESTION, THE SET SCREW GOT STRIPPED. A SPARE SCREWDRIVER AND NEW SFX SET SCREW WERE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 X 37-41MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931595 ↗
• MalfunctionSep 13, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED ON AUGUST 19, 2022 THAT THE CENTER SETSCREW OF THIS IMPLANT WAS NOT TIGHTENED WHEN DISTRIBUTOR OPENED ITS PACKAGE FOR INVENTORY ENTRANCE INSPECTION. IT SEEMED TO BE IN THE WRONG POSITION. WHEN THE DISTRIBUTOR LOOSENED THE SET SCREW, THEY FOUND THIS THREAD TO BE WORN OUT. THIS REPORT INVOLVES ONE EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 X 37-41MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410959 ↗
• InjuryApr 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE WITH EXPEDIUM SYSTEM ON AN UNKNOWN DATE. ON (B)(6) 2021, IT WAS REPORTED THAT TWO RODS WHICH WERE APPLIED IN THE PRIMARY PROCEDURE HAD BROKEN OFF. ON (B)(6) THE PATIENT HAD A REVISION PROCEDURE (REPLACING RODS AND REINFORCING THE CONNECTOR). THE SURGEON EVALUATED THE SEVERITY OF THIS EVENT AS ¿MILD TO MODERATE.¿ IT WAS ALSO REPORTED THAT THE SURGEON WILL PROVIDE FURTHER INFORMATION. IT WAS ALSO REPORTED THAT THE REVISION PROCEDURE WAS NOT DESPERATELY REQUIRED. HOWEVER, THEY CHOSE THE REVISION PROCEDURE TO ALLEVIATE THE PAIN WHICH THE PATIENT HAD SUFFERED SINCE THE EVENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 X 37-41MM. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11624291 ↗
• MalfunctionJan 9, 2020Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE ONE (1) OF THE SFX CROSSLINK IMPLANT A4 HAD PROBLEMS WITH FINAL TIGHTENING. MOST LIKELY IMPLANT CROSS-THREADED. IT COULD NOT BE FINAL TIGHTEN EVEN WITH A DIFFERENT DRIVER SHAFT. THERE WAS NO ISSUE WITH DRIVER SHAFT. THERE WAS SURGICAL DELAY OF ONE (1) MINUTE. A DIFFERENT IMPLANT WITH SAME PRODUCT CODE WAS USED TO COMPLETE THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED. DURING MANUFACTURER'S INVESTIGATION OF THE DEVICE ON DECEMBER 17, 2019, IT IS OBSERVED THAT THE MALE CROSS CONNECTOR BODY GOT STUCK IN THE MAIN ASSEMBLY. X20 ROUNDED SET SCREW GOT JAMMED AND IT¿S HEAD PART GOT STRIPPED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRIVER SHAFT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571686 ↗

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