EXPEDIUM VIPERRecalls & reported problems across all models

We found 5 models of EXPEDIUM VIPER by Depuy Spine, LLC in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2017 and Jul 30, 2025 — classified as 71 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (84 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EXPEDIUM VIPER problems

EXPEDIUM VIPER models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EXPEDIUM VIPER 196789480

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  72 reports
• EXPEDIUM VIPER 196789300

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  18 reports
• EXPEDIUM VIPER 196789600

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  10 reports
• EXPEDIUM VIPER 196789120

  APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  2 reports
• EXPEDIUM VIPER 196788120

  Orthosis, spinal pedicle fixation, for degenerative disc disease
  1 report

Recent EXPEDIUM VIPER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, WHEN THE ROD IN QUESTION WAS CONNECTED TO THE ROD HOLDER, IT COULD NOT CONNECT. THE NEW PRODUCT WAS OPENED AND USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663500 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THIS WAS A POSTERIOR FUSION (L5-S1) FOR SPONDYLOLISTHESIS ON (B)(6)2025. DURING SURGERY, WHEN USING THE ROD IN QUESTION, THE ROD IN QUESTION COULD NOT CONNECT TO THE VIPER-PRIME ROD FOLDER. A SPARE ROD WAS USED SO THE PATIENT WAS NOT AFFECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638468 ↗
• InjuryOct 25, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR FUSION (T9-S1) FOR SPINAL CANAL STENOSIS ON (B)(6).2014. ON (B)(6).2024, THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SAI SCREW. THE SURGEON REMOVED THE SAI SCREW AS SCHEDULED. DURING SURGERY, IT WAS CONFIRMED THAT THE ROD WAS BROKEN BETWEEN L2/L3. IN ADDITION, ONE SCREW WAS CONFIRMED AS POSSIBLY LOOSE, SO THE SURGEON REPLACED IT WITH A COMBINATION OF ARTIFICIAL BONE. COCR ROD WAS USED IN THE INITIAL SURGERY, BUT TITANIUM ALLOY WAS USED IN THE SECOND SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE. THIS PC CAPTURES THE ROD BREAKAGE AND POSSIBLE SCREW LOOSENING THAT WAS FOUND DURING THE SECOND SURGERY. (B)(4) CAPTURES FROM THE FIRST SURGERY TO THE SECOND SURGERY THAT REMOVED THE SAI SCREW.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533447 ↗
• 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 AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 600MM. THIS IS REPORT 2 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED

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

  MAUDE report 19338148 ↗
• 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 AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 600MM. THIS IS REPORT 1 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO

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

  MAUDE report 19338147 ↗
• InjuryApr 3, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN POLAND AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN THAT THE PATIENT WAS OPERATED ON IN (B)(6) 2020 IN MID (B)(6) THIS YEAR SHE CAME TO US WITH PAIN IN THE OPERATED AREA. A BROKEN ROD HAS BEEN FOUND IN THE X-RAY. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19032744 ↗
• InjuryJan 9, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: PATIENT ORIGINALLY UNDERWENT SPINE SURGERY ON (B)(6) 2005. ON (B)(6) 2015, PATIENT UNDERWENT REVISION SURGERY DUE TO ROD BREAKAGE. THE RE-FUSION WAS DONE WITH SCREWS. ON (B)(6) 2023, PATIENT UNDERWENT A SECOND REVISION PROCEDURE DUE TO ROD RE-BREAKAGE. DURING THE PROCEDURE, A SET SCREW AND CONNECTOR BROKE. PATIENT WAS STABLE. THIS REPORT IS FOR A VIPER2 STRAIGHT ROD-600MM, COC. THIS IS REPORT 2 OF 2 FOR (B)(4) AND CAPTURES THE FIRST REVISION SURGERY. THE SECOND REVISION SURGERY IS CAPTURED UNDER (B)(4). THE INTRAOPERATIVE INCIDENT IS CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479497 ↗
• InjuryJan 9, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: PATIENT ORIGINALLY UNDERWENT SPINE SURGERY ON (B)(6) 2005. ON (B)(6) 2015, PATIENT UNDERWENT REVISION SURGERY DUE TO ROD BREAKAGE. THE RE-FUSION WAS DONE WITH SCREWS. ON (B)(6) 2023, PATIENT UNDERWENT A SECOND REVISION PROCEDURE DUE TO ROD RE-BREAKAGE. DURING THE PROCEDURE, A SET SCREW AND CONNECTOR BROKE. PATIENT WAS STABLE. THIS REPORT IS FOR A VIPER2 STRAIGHT ROD-600MM, COC. THIS IS REPORT 1 OF 2 FOR (B)(4) AND CAPTURES THE FIRST REVISION SURGERY. THE SECOND REVISION SURGERY IS CAPTURED UNDER (B)(4). THE INTRAOPERATIVE INCIDENT IS CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479369 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE EVENTS OCCURRED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS INVOLVED IN THE EVENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17878367 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) (L4/5) WAS PERFORMED ON (B)(6) 2018. AFTER THE INITIAL SURGERY, ADJACENT SEGMENT DISEASE OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THIS REPORT INVOLVES ONE EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE EVENTS OCCURRED IN THE REVISION SURGERY. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPLANTS INVOLVED IN THE EVENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Osteolysis

  MAUDE report 17878363 ↗
• MalfunctionAug 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE SCREW REPLACEMENT PERFORMED IN THE REVISION SURGERY ON (B)(6), 2021. THIS PC REPORTS ABOUT THE ROD BREAKAGE FOUND IN THE REMOVAL SURGERY ON (B)(6), 2023. IT WAS REPORTED THAT THIS WAS A PPS (L3-5) FOR A FRACTURE OF L4 ON (B)(6), 2021. AFTER THE INITIAL SURGERY, A REVISION SURGERY WAS PERFORMED ON (B)(6), 2021, AND THE VIPER MONOAXIAL SCREW 7×45 MM INSERTED INTO L3 RIGHT WAS REPLACED WITH A PRIME SCREW 7×45 MM. AFTER THE REVISION SURGERY, A REMOVAL SURGERY WAS PERFORMED ON (B)(6), 2023, BECAUSE BONE UNION WAS CONFIRMED. DURING THE REMOVAL SURGERY, IT WAS FOUND THAT THE ROD (196789300) THAT HAD BEEN INSTALLED ON THE LEFT SIDE WAS BROKEN JUST ABOVE THE SCREW AT L4. THE REMOVAL OF THE ROD ITSELF WAS DONE WITH NO PROBLEMS. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO IMPACT ON THE PATIENT DUE TO THE ROD BREAKAGE AND NO SYMPTOMS, ETC. THE EXACT DATE OF THE ROD BREAKAGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED - UNK - SCREWS: VIPER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633819 ↗
• InjuryJun 8, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS PC IS RELATED TO (B)(4), AND (B)(4). THIS PC REPORTS ABOUT THE BACK PAIN AND BREAKAGE OF THE RODS OCCURRED AFTER THE VCR PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT AFTER THE VCR, WHEN THE PATIENT TWISTED HIS/HER BACK TO GET SOMETHING FROM THE REFRIGERATOR ON (B)(6) 2023. HE/SHE BEGAN TO HAVE BACK PAIN, WHICH GRADUALLY WORSENED. ON (B)(6) 2023, THE PATIENT WAS EXAMINED AND FOUND THAT THE BILATERAL RODS INSTALLED IN 5/S WERE BROKEN. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17088328 ↗
• InjuryJun 8, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS PC IS RELATED TO (B)(4) AND (B)(4). THIS PC REPORTS ABOUT THE BACK PAIN AND BREAKAGE OF THE RODS OCCURRED AFTER THE VCR PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT AFTER THE VCR, WHEN THE PATIENT TWISTED HIS/HER BACK TO GET SOMETHING FROM THE REFRIGERATOR ON (B)(6) 2023, HE/SHE BEGAN TO HAVE BACK PAIN, WHICH GRADUALLY WORSENED. ON (B)(6) 2023, THE PATIENT WAS EXAMINED AND FOUND THAT THE BILATERAL RODS INSTALLED IN 5/S WERE BROKEN. ON (B)(6) 2023, A REOPERATION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 17088321 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT THE VIPER2 STRAIGHT ROD480MM COCR SNAPPED DURING IN-SITU BENDING. 199721000 _ CORRECTION KEYS X 2 THREADS OF SET SCREWS WERE SHEARED BY BLUNT TIP OF DRIVER. SURGERY WAS NOT DELAYED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) VIPER2 STRAIGHT ROD480MM, COCR THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328484 ↗
• MalfunctionSep 15, 2022Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED TO REMOVE OSTEOSYNTHESIS MATERIAL OF THE SPINE (EXPEDIUM 5.5 SYSTEM) BECAUSE ONE OF THE SCREWS IMPLANTED IN THE PATIENT BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR AN EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 300MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15428118 ↗

Other Depuy Spine, LLC products

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• UNIPLATE6 models · 56 reports
• ISOLA8 models · 43 reports
• EXPEDIUM TOP NOTCH2 models · 42 reports
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