EXPEDIUM 179788640Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705034081397), received between May 1, 2018 and May 16, 2024 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (6 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 14 most recent of 14 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 (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 40MM THIS IS REPORT 3 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO TH

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

  MAUDE report 19338150 ↗
• 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 40MM. THIS IS REPORT 6 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS

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

  MAUDE report 19338149 ↗
• 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 40MM THIS IS REPORT 4 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO TH

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

  MAUDE report 19338146 ↗
• 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 40MM THIS IS REPORT 5 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS

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

  MAUDE report 19338145 ↗
• 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 40MM THIS IS REPORT 8 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THI

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

  MAUDE report 19338144 ↗
• 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 40MM THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO TH

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

  MAUDE report 19338143 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON (B)(6) 2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 40MM. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484960 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SURGERY WAS PERFORMED FOR ADOLESCENT IDIOPATHIC SCOLIOSIS. AFTER THE SURGERY ON 18-DECEMBER-2023, AN INFECTION WAS CONFIRMED ON THE CONCAVE SIDE. A REVISION PROCEDURE WAS SCHEDULED FOR AND PERFORMED ON (B)(6) 2023. THE SET SCREWS ON T2, 3, 4, AND 5 ON THE LEFT WERE REMOVED. THE ROD WHERE THE SET SCREWS WERE REMOVED WERE CUT AND REMOVED. FOUR UNIPLANAR SCREWS WERE REMOVED ON THE LEFT OF T2-T5. THE AFFECTED AREA WAS WASHED, AND A HOOK WAS PLACED ON T2. A SIDE-SIDE CONNECTOR WAS INSTALLED AT THE UPPER END OF T5, AND TITANIUM ROD CONNECTION WAS PERFORMED BETWEEN T2 AND T5. THE WOUND WAS CLOSED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 40MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18484945 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902687 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION FUSION: (B)(6), (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2018. REVISION FOR DISLODGED RODS. SET SCREWS WERE NO LONGER IN SCREW HEADS RIGHT SIDE ROD NO LONGER STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY ONE). THIS COMPLAINT INVOLVES 11 (ELEVEN) DEVICES.

  Patient problems: No Code Available

  MAUDE report 8902281 ↗
• MalfunctionJan 22, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT DR. (B)(6) WAS PERFORMING A POSTERIOR SPINAL FUSION TODAY. UPON FINAL TIGHTENING OF THE SET SCREW, IT WAS REVEALED THAT SET SCREW WOULD NOT PROPERLY TIGHTEN. DR. (B)(6) TRIED A FEW DIFFERENT THINGS TO SEE IF IT WOULD TORQUE, IT WOULD NOT. HE THEN REMOVED THE ROD FROM THE SCREW, REMOVED THE SCREW IN QUESTION AND PLACED A NEW SCREW. ONCE THE NEW SCREW WAS IN, THE CONSTRUCT WAS FINAL TIGHTENING TO PROPER SPECIFICATIONS. THE UNIPLANER SCREW THAT CAME OUT WAS DAMAGED SIGNIFICANTLY. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE: REMOVED DAMAGED UNIPLANER SCREW AND REPLACED IT WITH A NEW UNIPLANER SCREW. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268707 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  SCOLIOSIS FUSION WAS PERFORMED 2016. SET SCREW SEEMED TO SLIP ON POST OPT MONTH 3. CONTINUED TO SLIP UNTIL THE ROD SLIPPED INTO THE TULIP HEAD OF THE SCREW. PSEUDO OCCURRED. REVISED ON (B)(6) 2018 AND FOUND THAT SET SCREWS WERE LOOSE AND MOST DISTAL SCREW HEAD WAS POPPED OFF. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:THERE WAS NO MAJOR ISSUE. ROD WAS CUT. THREE SCREWS WERE REMOVED. THREE SCREWS WERE REPLACED WITH LARGER DIAMETER SCREWS, AND AN INLINE ROD CONNECTOR WAS PLACED. BONE GRAFT WAS PLACED AND PATIENT WAS CLOSED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7475614 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  SCOLIOSIS FUSION WAS PERFORMED 2016. SET SCREW SEEMED TO SLIP ON POST OPT MONTH 3. CONTINUED TO SLIP UNTIL THE ROD SLIPPED INTO THE TULIP HEAD OF THE SCREW. PSEUDO OCCURRED. REVISED ON (B)(6) 2018 AND FOUND THAT SET SCREWS WERE LOOSE AND MOST DISTAL SCREW HEAD WAS POPPED OFF. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:THERE WAS NO MAJOR ISSUE. ROD WAS CUT. THREE SCREWS WERE REMOVED. THREE SCREWS WERE REPLACED WITH LARGER DIAMETER SCREWS, AND AN INLINE ROD CONNECTOR WAS PLACED. BONE GRAFT WAS PLACED AND PATIENT WAS CLOSED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7475448 ↗
• InjuryMay 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  SCOLIOSIS FUSION WAS PERFORMED 2016. SET SCREW SEEMED TO SLIP ON POST OPT MONTH 3. CONTINUED TO SLIP UNTIL THE ROD SLIPPED INTO THE TULIP HEAD OF THE SCREW. PSEUDO OCCURRED. REVISED ON (B)(6) 2018 AND FOUND THAT SET SCREWS WERE LOOSE AND MOST DISTAL SCREW HEAD WAS POPPED OFF. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:THERE WAS NO MAJOR ISSUE. ROD WAS CUT. THREE SCREWS WERE REMOVED. THREE SCREWS WERE REPLACED WITH LARGER DIAMETER SCREWS, AND AN INLINE ROD CONNECTOR WAS PLACED. BONE GRAFT WAS PLACED AND PATIENT WAS CLOSED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7475359 ↗