EXPEDIUM VIPER 196789600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034295282), received between Oct 2, 2017 and May 16, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K090648, K111136); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 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 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 ↗
• 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 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE VIPER2 STRAIGHT ROD-600MM, COC WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) NUMBER OF DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD-600MM, COC. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848979 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE VIPER2 STRAIGHT ROD-600MM, COC WERE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) NUMBER OF DEVICES. THIS REPORT IS FOR (1) VIPER2 STRAIGHT ROD-600MM, COC. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848974 ↗
• InjuryJul 31, 2018Break; Break

  FURTHER TO (B)(4), ON (B)(6) 2018, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO A LOWER BACK PAIN, THE BREAKAGE OF THE ROD (196789600) WAS FOUND UNDER THE X-RAY BETWEEN L4 AND L5 (RIGHT), AND BETWEEN L5 AND S (LEFT). ON (B)(6) 2018, THE RE-OPERATION WAS RESCHEDULED DUE TO THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL. ON (B)(6) 2018, THE RE-OPERATION WAS PERFORMED TO FIND THE CAUSE OF THE PATIENT¿S HIGH CRP (C-REACTIVE PROTEIN) LEVEL, CONSIDERING THE SUSPECTED INFECTIONS. THE PROCEDURES WERE CONDUCTED IN THE FOLLOWING WAY. - SCREWS AT L4, L5 AND S1 (RIGHT) WERE EXTRACTED AND NEW SCREWS WERE INSERTED AT L5 AND S1 TO CONNECT WITH UPPER RODS USING A CONNECTOR. - A SCREW AT L5 (LEFT) WAS EXTRACTED TO CONNECT WITH UPPER RODS USING A CONNECTOR. - SI SET SCREWS AT L4 AND OVER (BOTH SIDES) WERE REPLACED WITH NEW ONES, AND RODS AT FAR END WERE ALSO REPLACED WITH NEW ONES. ALSO, THE FOLLOWING WERE COMMENTED BY THE SURGEON. - LOOSENING OF ALL THE SCREWS WERE OBSERVED WHEN EXTRACTED - TORQUE WAS NOT PROPERLY APPLIED TO SI SET SCREWS WHEN EXTRACTED. - BLACK-COLORED SUBSTANCES WERE SEEN AROUND THE SCREW AND THE ROD, WHICH MIGHT HAVE BEEN CAUSED BY THE METAL CORROSION. - THE PATIENT¿S CRP LEV

  Patient problems: Spinal Column Injury; Unspecified Infection

  MAUDE report 7736313 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PRIMARY SURGERY WAS PERFORMED TO FIX T10 ¿ SAI. ON (B)(6) 2017, DUE TO UNKNOWN REASONS, THE EXTENSION SURGERY WAS PERFORMED TO FIX T7 ¿ SAI. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

  Patient problems: Spinal Column Injury

  MAUDE report 7734790 ↗
• InjuryOct 2, 2017Break; Break

  REVISION SCOLIOSIS CORRECTION ON (B)(6) 2017. PATIENT UNDERWENT PRIMARY CORRECTION (B)(6) 2010. 3 YEARS AGO THE PATIENT HAD A FALL AND THE SCREWS BROKE JUST UNDER THE TULIP AND THE COCR RODS ALSO BROKE. X-RAY PROVIDED. CASE IS LINKED TO 5109967 - THIS CASE CAPTURES THE INSTRUMENT ISSUES THAT OCCURRED DURING THE REVISION PROCEDURE.

  Patient problems: Failure of Implant; Fall; Injury

  MAUDE report 6906915 ↗
• InjuryOct 2, 2017Break; Break

  REVISION SCOLIOSIS CORRECTION ON (B)(6) 2017. PATIENT UNDERWENT PRIMARY CORRECTION (B)(6) 2010. THREE (3) YEARS AGO THE PATIENT HAD A FALL AND THE SCREWS BROKE JUST UNDER THE TULIP AND THE COCR RODS ALSO BROKE. X-RAY PROVIDED. CASE IS LINKED TO (B)(4) - THIS CASE CAPTURES THE INSTRUMENT ISSUES THAT OCCURRED DURING THE REVISION PROCEDURE.

  Patient problems: Failure of Implant; Fall; Injury

  MAUDE report 6906896 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090648, K111136. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2015 · Apr 21, 2015 · Terminated
  EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467