EXPEDIUM 179788630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034081373), received between May 16, 2024 and May 16, 2024 — classified as 2 injuries.

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

• InjuryMay 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICLE SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6) 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON AUGUST 04, 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 30MM THIS IS REPORT 10 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO

  Patient problems: Deformity/ Disfigurement; Necrosis; Pain; Spinal Cord Injury

  MAUDE report 19338142 ↗
• InjuryMay 16, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON OR ABOUT (B)(6), 2020 A DEPUY SPINAL WAS USED IN PATIENT SURGERY. UPON INFORMATION, THE PRODUCT USED IN PATIENT SURGERY INCLUDE DEPUY EXPEDIUM, COBALT CHROMIUM RODS, UNIAXIAL PEDICLE SCREWS, DEPUY SPINE SCREWS, ROD VIPER STRAIGHT AND OR OTHER ASSOCIATED DEVICES. THE PATIENT HAD SOME PAIN POSTOPERATIVELY AND ALSO HAD DESCRIPTIONS OF CRACKING AND POPPING INVOLVING HER LUMBOSACRAL SPINE. X-RAY REVEALED A DISENGAGEMENT OF THE LEFT-SIDED ROD FROM HER L3 PEDICLE SCREW AND THE PATIENT'S CORONAL BALANCE ALSO APPEARED TO BE SIGNIFICANTLY AFFECTED. PATIENT WAS CAUSED TO SUSTAIN SEVERE, SERIOUS, PERMANENT INJURIES THAT HAD RENDERED HER SICK LORE, LAME AND DISABLED. ALSO NOTED THE PATIENT EXPERIENCED NECROSIS. ON (B)(6), 2020 THE PATIENT UNDERWENT REINSERTION OF SPINAL FIXATION DEVICE WITH REVISION OF INSTRUMENTATION DUE TO POSTERIOR INSTRUMENTED SPINAL FUSION HARDWARE FAILURE. ON (B)(6), 2020 THE PATIENT UNDERWENT EXCISIONAL DEBRIDEMENT OF SKIN INCLUDING THE SUBCUTANEOUS LEVEL AND FASCIA, RIGHT SIDE AND LEFT SIDE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 30MM THIS IS REPORT 9 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO TH

  Patient problems: Deformity/ Disfigurement; Necrosis; Pain; Spinal Cord Injury

  MAUDE report 19338141 ↗