EXPEDIUM 179712045Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034066592), received between Oct 27, 2017 and Sep 19, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TOP OF THE PEDICLE SCREW THAT ENGAGES WITH THE HEAD OF THE SCREW POPPED UP INTO THE HEAD WHILE THE SCREW WAS BEING INSERTED. THE SCREW HAD TO BE REMOVED AND REPLACED DUE TO THE PIECE BEING IN THE WAY OF PUTTING A ROD INTO PLACE. THERE WAS A SURGICAL DELAY OF 10 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7.5 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446613 ↗
• InjuryDec 6, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2019 SURGEON REVISED A LUMBAR FUSION CONSTRUCT (L2-L5), THE SET SCREW AT THE TOP OF THE CONSTRUCT (L2 LEFT PEDICLE) HAD BECOME DISLODGED FROM THE TULIP HEAD AND WAS ADJACENT TO THE CONSTRUCT ON THE LEFT SIDE. SURGEON OBSERVED "HALOING" AROUND THE L2 PEDICLE SCREWS BILATERALLY AND INTENDED TO REVISE. THE RIGHT SIDE OF THE CONSTRUCT WAS SECURELY INTACT, RODS REMOVED BILATERALLY AND REPLACED THE R SIDE L2 CORTICAL FIX POLYAXIAL SCREW 7 X 45 MM WITH A HALF DIAMETER LARGER EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 7.5 MM X 45 MM. SURGEON CONTINUED ON TO REMOVE THE HARDWARE BELOW (SPINEART ROMEO PEDICLE SCREW SYSTEM AT L3-5) AND REPLACED THE HARDWARE WITH EXPEDIUM 5.5 AND PROCEEDED TO EXPOSURE, CANNULATE, AND PLACE BILATERAL PEDICLE SCREWS AT L1, THEN PLACED A 5.5. TI ROD FROM L1-4 (04.636.125 X 2), INSERTED NEW SINGLE INNER SET CAPS AND SUCCESSFULLY FINAL TIGHTENED WITH THE TORQUE DRIVER AND COUNTER TORQUE WITHOUT INCIDENT. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS IS 3 OF 5 FOR REPORT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9426306 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY.

  Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

  MAUDE report 7263990 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY.

  Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

  MAUDE report 7263838 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY. SEE ATTACHMENT "PATIENT MEDICAL HISTORY SUMMARY"

  Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

  MAUDE report 7263648 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY.

  Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

  MAUDE report 7263534 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT PATIENT HAD SEVERAL POST OP ISSUES FOLLOWING POSTERIOR SPINAL INSTRUMENTATION WITH DEPUY EXPEDIUM (L5-S1). LEFT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH PLACEMENT OF A DEPUY DEVEX 10 X 28 TRANSFORAMINAL LUMBAR INTERBODY FUSION TITANIUM CAGE AND ANTERIOR SPINAL FUSION WITH AUTOGRAFT AT L5-S1. UNEVENTFUL SURGERY PER OP REPORT. NOTHING OUT OF THE ORDINARY.

  Patient problems: Dizziness; Hypersensitivity/Allergic reaction; Neurological Deficit/Dysfunction

  MAUDE report 7263520 ↗
• MalfunctionOct 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER IMPLANTING THE SCREW, THE SURGEON REMOVED A LOOSE PIECE OF A SCREW. IT WAS THE ¿U¿ SHAPED PIECE INSIDE THE POLYAXIAL HEAD OF THE SCREW. HE REMOVED THE SCREW AND REPLACED IT WITH ANOTHER ONE OF THE SAME SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984558 ↗