EXPEDIUM 179722940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034071138), received between Nov 6, 2025 and Nov 6, 2025 — classified as 2 injuries.

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.

• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON-JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23491035 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REOPERATION ON (B)(6) 2023 WITH L3-S SCREW REMOVAL, L2/3 TLIF (NON JJ PRODUCT: TRITANIUM), L2-SAI SCREW INSERTION (JJ PRODUCTS: VERSEFS, EXPEDIUM DI, AND EXPEDIUM SAI). ON (B)(6) 2025, A L1/2 TLIF WAS PERFORMED DUE TO ADJACENT SEGMENT DYSFUNCTION. L2 TO SAI WERE LEFT AS IS. VERSEFS (1.8CC CEMENT EACH) WAS USED FOR L1, AND RISE (GLOBUS) WAS USED FOR L1/2. CRANK RODS (NUVASIVE) AND ROD CONNECTORS WERE USED TO CONNECT TO THE EXISTING RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THE SALES REP RECEIVED A COMPLAINT AFTER A CT SCAN ON (B)(6) 2025, SHOWED BILATERAL BREAKAGE OF THE L1 SCREW IN A PATIENT WHO UNDERWENT L1/2 TLIF (VERSEFS + RISE (GLOBUS)). THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW. IT IS CURRENTLY UNDECIDED WHETHER OR NOT TO PERFORM SURGERY ON THIS PATIENT IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT AND (B)(4) REPORTS THE REVISION SURGERY PERFORMED ON (B)(6) 2025 WHILE RELATED (B)(4) REPORTS THE BREAKAGE OF THE SCREW OCCURRED AFTER THE SURGERY PERFORMED ON (B)(6) 2025.

  Patient problems: Osteolysis

  MAUDE report 23490968 ↗