EXPEDIUM 189662600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034178639), received between Jul 20, 2023 and Jul 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY. AFTER THE PROCEDURE IT WAS NOTICED THAT THE RODS HAD DISLODGED FROM THE SCREW HEADS OF THE PELVIC SCREWS. A REVISION SURGERY WAS PERFORMED ON (B)(6)2023 FOR RODS PULLING OUT OF THE SCREWS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17361813 ↗
• InjuryJul 20, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY. AFTER THE PROCEDURE IT WAS NOTICED THAT THE RODS HAD DISLODGED FROM THE SCREW HEADS OF THE PELVIC SCREWS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 FOR RODS PULLING OUT OF THE SCREWS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 6.35 X 600MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17361811 ↗