VIPER 186715000Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 10705034121192), received between Oct 18, 2017 and Oct 23, 2025 — classified as 1 death, 142 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (42 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 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON PERFORMED A PLIF (L5/S1) FOR DEGENERATIVE DISEASE. DURING THE SURGERY, A TIP OF THE SCREWDRIVER BROKE AND WAS LEFT IN THE SET SCREW WHEN THE SURGEON ADDED COMPRESSION. THE SURGEON BROKE THE SET SCREW WITH A METAL CUTTER. THE ROD, SCREW, AND SET SCREW WERE REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372344 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21053874 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE SURGEON STATED HE IS NEW TO USING TRIALTIS AND HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21036817 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD BEEN IMPLANTED WITH THE TRIALTIS THORACOLUMBAR SYSTEM AND DEVELOPED AN INFECTION. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2024. THE SURGEON INCIDENT HE IS NEW TO USING TRIALTIS AND STATES HE TYPICALLY DOES NOT SEE INFECTIONS; HE IS CONCERNED THE INFECTIONS MAY BE RELATED TO THE IMPLANTS AND INSTRUMENTATION. IN ADDITION TO IMPLANTING TRIALTIS, CONFIDENCE BONE CEMENT WAS USED.

  Patient problems: Unspecified Infection

  MAUDE report 21036003 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINAL FUSION ON (B)(6) 2024. OVER THE FOLLOWING WEEKEND, THE PATIENT PRESENTED WITH AN INFECTION. PATIENT HAD BEEN IMPLANTED WITH TRIALTIS THORACOLUMBAR SYSTEM. IN ADDITION TO IMPLANTING TRIALTIS, THE SURGEON USED CONFIDENCE BONE CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21035840 ↗
• MalfunctionAug 2, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINA FUSION ON (B)(6) 2024. WHILE INSERTING THE INNIE, THE THREAD IN THE SCREW HEAD BROKE AND THE INNIE COULD NOT BE INSERTED ANYMORE. SURGEON EXCHANGE THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THREE SCREWS WERE RETURNED FOR MANUFACTURER INVESTIGATION. THIS REPORT IS FOR A MIS SINGLE INNER SETSCREW. THIS IS REPORT 3 OF 3 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19893804 ↗
• MalfunctionAug 2, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT SPINA FUSION ON (B)(6) 2024. WHILE INSERTING THE INNIE, THE THREAD IN THE SCREW HEAD BROKE AND THE INNIE COULD NOT BE INSERTED ANYMORE. SURGEON EXCHANGE THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THREE SCREWS WERE RETURNED FOR MANUFACTURER INVESTIGATION. THIS REPORT IS FOR A MIS SINGLE INNER SETSCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19893800 ↗
• InjuryMay 22, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT CST AFTER THORACIC SPONDYLODESIS TH11-L5 WITH NON-SYNTHES SYSTEM IN EXTERNAL CLINIC, TIME UNKNOWN, DATE UNKNOWN. IN JANUARY 2024, SACRAL FRACTURE TREATMENT WITH VIPER SAI SCREWS AND EXP CONNECTORS TO EXTEND DORSAL SPONDYLODESIS TO LUMBOPELVIC FIXATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION OF THE LUMBOPELVIC STABILIZATION. THE RIGHT ROD SLIPPED OUT OF THE VIPER SAI HEAD, THE LEFT ROD SLIPPED OUT OF THE EXP CONNECTOR, HERE THE INNIE WAS LOOSENED. THE CONNECTORS WERE FIRMLY FIXED ON BOTH SIDES OF THE NON-SYNTHES CONSTRUCT. DURING THE REVISION SURGERY ON (B)(6), LONGER RODS (100 MM) AND NEW INNIES WERE USED. THE VIPER SAI SCREWS WERE LEFT IN PLACE AS THEY WERE PROPERLY ANCHORED IN THE BONE. THIS REPORT IS FOR A MIS SINGLE INNER SETSCW. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19374999 ↗
• InjuryMay 22, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT CST AFTER THORACIC SPONDYLODESIS TH11-L5 WITH NON-SYNTHES SYSTEM IN EXTERNAL CLINIC, TIME UNKNOWN, DATE UNKNOWN. IN (B)(6) 2024, SACRAL FRACTURE TREATMENT WITH VIPER SAI SCREWS AND EXP CONNECTORS TO EXTEND DORSAL SPONDYLODESIS TO LUMBOPELVIC FIXATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION OF THE LUMBOPELVIC STABILIZATION. THE RIGHT ROD SLIPPED OUT OF THE VIPER SAI HEAD, THE LEFT ROD SLIPPED OUT OF THE EXP CONNECTOR, HERE THE INNIE WAS LOOSENED. THE CONNECTORS WERE FIRMLY FIXED ON BOTH SIDES OF THE NON-SYNTHES CONSTRUCT. DURING THE REVISION SURGERY ON (B)(6), LONGER RODS (100 MM) AND NEW INNIES WERE USED. THE VIPER SAI SCREWS WERE LEFT IN PLACE AS THEY WERE PROPERLY ANCHORED IN THE BONE. THIS REPORT IS FOR A MIS SINGLE INNER SETSCW. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19374998 ↗
• InjuryMay 22, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT CST AFTER THORACIC SPONDYLODESIS TH11-L5 WITH NON-SYNTHES SYSTEM IN EXTERNAL CLINIC, TIME UNKNOWN, DATE UNKNOWN. IN (B)(6) 2024, SACRAL FRACTURE TREATMENT WITH VIPER SAI SCREWS AND EXP CONNECTORS TO EXTEND DORSAL SPONDYLODESIS TO LUMBOPELVIC FIXATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO DISLOCATION OF THE LUMBOPELVIC STABILIZATION. THE RIGHT ROD SLIPPED OUT OF THE VIPER SAI HEAD, THE LEFT ROD SLIPPED OUT OF THE EXP CONNECTOR, HERE THE INNIE WAS LOOSENED. THE CONNECTORS WERE FIRMLY FIXED ON BOTH SIDES OF THE NON-SYNTHES CONSTRUCT. DURING THE REVISION SURGERY ON (B)(6), LONGER RODS (100 MM) AND NEW INNIES WERE USED. THE VIPER SAI SCREWS WERE LEFT IN PLACE AS THEY WERE PROPERLY ANCHORED IN THE BONE. THIS REPORT IS FOR A MIS SINGLE INNER SETSCW. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19374977 ↗
• InjuryMay 22, 2024Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT CST AFTER THORACIC SPONDYLODESIS TH11-L5 WITH NON-SYNTHES SYSTEM IN EXTERNAL CLINIC, TIME UNKNOWN, DATE UNKNOWN. IN (B)(6) 2024, SACRAL FRACTURE TREATMENT WITH VIPER SAI SCREWS AND EXP CONNECTORS TO EXTEND DORSAL SPONDYLODESIS TO LUMBOPELVIC FIXATION. REVISION SURGERY WAS PERFORMED ON (B)(6), 2024, DUE TO DISLOCATION OF THE LUMBOPELVIC STABILIZATION. THE RIGHT ROD SLIPPED OUT OF THE VIPER SAI HEAD, THE LEFT ROD SLIPPED OUT OF THE EXP CONNECTOR, HERE THE INNIE WAS LOOSENED. THE CONNECTORS WERE FIRMLY FIXED ON BOTH SIDES OF THE NON-SYNTHES CONSTRUCT. DURING THE REVISION SURGERY ON (B)(6) 26, LONGER RODS (100 MM) AND NEW INNIES WERE USED. THE VIPER SAI SCREWS WERE LEFT IN PLACE AS THEY WERE PROPERLY ANCHORED IN THE BONE. THIS REPORT IS FOR A MIS SINGLE INNER SETSCW. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19374974 ↗
• 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 AUGUST 03, 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 9 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE

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

  MAUDE report 19338160 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 9 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE C

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

  MAUDE report 19338159 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 8 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE C

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

  MAUDE report 19338158 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 5 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338157 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 2 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338156 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 1 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338155 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338154 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 6 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE C

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

  MAUDE report 19338153 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 4 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338152 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 3 OF 10 FOR (B)(4). . ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CA

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

  MAUDE report 19338151 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338128 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 9 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CAPT

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

  MAUDE report 19338127 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 10 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE

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

  MAUDE report 19338124 ↗
• 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 VIPER SYSTEM SINGLE INNER SET SCREW 5.5. THIS IS REPORT 8 OF 10 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT ARE CA

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

  MAUDE report 19338123 ↗