EXPEDIUM 179732745Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034074047), received between Jun 29, 2020 and Dec 27, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD AN L4-5 TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) ON (B)(6) 2022 WITH THE EXPEDIUM SCREWS AND A NON-SYNTHES EXPANDABLE CAGE. UPON POST-OP FOLLOWUP ON AUGUST 2, 2023, THE SURGEON DISCOVERED A BROKEN SCREW AT L5 RIGHT. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024 FOR IMPLANT REMOVAL AND CONSTRUCT EXTENSION. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399543 ↗
• MalfunctionSep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHEN SCREWING THE PEDICLE SCREW DURING SURGERY, THE SCREW ROD SEPARATED FROM THE LONG TAIL OF SCREW CAP. THE SURGEON REMOVED THE DETACHED SCREW ROD AND CAP FROM THE PATIENT, AND CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THIS CAUSED THE SURGERY TO BE EXTENDED FOR ABOUT 1.5 HOURS. THE PATIENT IS REPORTED AS STABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427188 ↗
• InjuryAug 1, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION PROCEDURE, LUMBAR SPINAL FUSION. AFTER REMOVING A SCREW, THE SURGEON MOVED ON TO INSERTING A CFS 8MM SCREW WITH THE SCREWDRIVER. THEN, THE SCREWDRIVER¿S TIP BROKE OFF. THE FRAGMENTED TIP WAS IMMOVABLE IN THE SCREW¿S SHANK AND HAS BEEN LEFT IN THE LESION. THIS REPORT INVOLVES ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15140685 ↗
• MalfunctionJun 29, 2020Material Deformation; Material Deformation

  THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205691 ↗