EXPEDIUM 179712545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034067568), received between Jan 26, 2021 and Oct 31, 2025 — classified as 3 injuries, 1 malfunction.

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

• InjuryOct 31, 2025Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT THE ORIGINAL PROCEDURE IN 2023. SINCE THEN IT WAS NOTED THE SCREW IS CRACKED AND PATIENT NEEDS TO UNDERGO A REVISION PROCEDURE TO CORRECT IT.

  Patient problems: Insufficient Information

  MAUDE report 23437808 ↗
• InjuryNov 10, 2021Break; Entrapment of Device; Migration; Break; Entrapment of Device; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A LUMBAR FUSION WITH PEDICLE SCREW FIXATION USING THE DEPUY EXPENDIUM POLYAXIAL SYNTHES SCREW. THE PATIENT EXPERIENCED SEVERE BACK PAIN AND IT WAS DISCOVERED THAT THE SCREW HAD BEEN CUT INSIDE THE PATIENT. A REVISION OPERATION WAS PERFORMED ON (B)(6) 2021 WHERE PART OF THE SCREW WAS REMOVED. THE OTHER PART OF THE SCREW REMAINS INSIDE PATIENT'S BODY. THIS REPORT IS FOR (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 5 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 12786882 ↗
• MalfunctionSep 3, 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 THE LUMBER SPINE FIXATION DONE FOR L1-L5, NINE(9) SCREWS WERE USED. DURING SURGERY ONE SCREW WITH LOCKING CAP WAS DAMAGED AND THUS TAKEN OUT. THE IMPLANTS ARE GIVEN BACK TO DEALER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 8). THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 5 X 45MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421094 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON JANUARY 4, 2021 THAT THE PATIENT REPORTED AN ALLERGY AFTER BEING IMPLANTED WITH THE EXPEDIUM IMPLANTS ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) SI POLYAXL SCREW 5 X 45MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11232511 ↗