VIPER 186717645Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034123479), received between Feb 26, 2019 and Aug 3, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryAug 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, DURING THE FOLLOW-UP IT WAS FOUND ON (B)(6) 2021 THAT THE SCREW DEPLOYED AT TH12 RIGHT HAD BROKEN OFF. THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2021. IT WAS UNKNOWN IF THE REVISION PROCEDURE PERFORMED. THE PATIENT OUTCOME UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - SCREWS: DISTAL FEMUR. THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 12269370 ↗
• InjuryMar 16, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A PPS TO TREAT THE TRAUMATIC INJURY. ON (B)(6) 2021 X-RAYS WERE TAKEN WHICH REVEALED THAT TWO (2) SCREWS HAD BROKEN OFF IN THE CENTRUM. ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION PROCEDURE. THE FRAGMENTS WERE LEFT IN THE PATIENT'S BODY. OTHER IMPLANTS WERE SUCCESSFULLY EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 6X45MM TI. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 11498851 ↗
• InjuryMar 16, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A PPS TO TREAT THE TRAUMATIC INJURY. ON (B)(6) 2021 X-RAYS WERE TAKEN WHICH REVEALED THAT TWO (2) SCREWS HAD BROKEN OFF IN THE CENTRUM. ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION PROCEDURE. THE FRAGMENTS WERE LEFT IN THE PATIENT'S BODY. OTHER IMPLANTS WERE SUCCESSFULLY EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 6X45MM TI. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 11498850 ↗
• InjuryOct 7, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT WAS IN AN ACCIDENT IN (B)(6) AND TAKEN TO A (B)(6) TRAUMA CENTER FOR A T12 COMPRESSION FRACTURE. PATIENT WAS INSTRUMENTED PERCUTANEOUSLY FROM T10-L2 USING DSS VIPER SYSTEM LAST (B)(6) 2019. UPON RETURN TO THE US, PATIENT WAS BENDING AND HEARD/FELT A POP. HE CAME TO THE ER AND IMAGES REVEALED THE HARDWARE HAD DISASSEMBLED. SEVERAL SET SCREWS WERE DISPLACED AND THE ROD HAD COME OUT OF THE SCREW SADDLE. DURING THE REVISION SURGERY, ON (B)(6) 2019, IT WAS FOUND THAT ALL OF THE SET SCREWS WERE LOOSE AND SOME WERE SITTING EXTREMELY PROUD IN THE SCREW SADDLE. HARDWARE WAS REMOVED, REPLACED, AND SUFFICIENTLY LOCKED. THERE WAS A HARDWARE FAILURE AND INFECTION. THERE WAS A PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: VIPER2 STRAIGHT ROD-160MM (PART# 186789160, LOT# UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180MM (PART# 186789180, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9161320 ↗
• InjuryOct 3, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON AN UNKNOWN DATE, PATIENT WAS IN AN ACCIDENT IN (B)(6) AND TAKEN TO A SWISS TRAUMA CENTER FOR A T12 COMPRESSION FRACTURE. PATIENT WAS INSTRUMENTED PERCUTANEOUSLY FROM T10-L2 USING DSS VIPER SYSTEM LAST (B)(6) 2019. UPON RETURN TO THE US, PATIENT WAS BENDING AND HEARD/FELT A POP. HE CAME TO THE ER AND IMAGES REVEALED THE HARDWARE HAD DISASSEMBLED. SEVERAL SET SCREWS WERE DISPLACED AND THE ROD HAD COME OUT OF THE SCREW SADDLE. DURING THE REVISION SURGERY, ON (B)(6) 2019, IT WAS FOUND THAT ALL OF THE SET SCREWS WERE LOOSE AND SOME WERE SITTING EXTREMELY PROUD IN THE SCREW SADDLE. HARDWARE WAS REMOVED, REPLACED, AND SUFFICIENTLY LOCKED. THERE WAS A HARDWARE FAILURE AND INFECTION. THERE WAS A PATIENT CONSEQUENCE. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: VIPER2 STRAIGHT ROD-160MM (PART# 186789160, LOT# UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180MM (PART# 186789180, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9152282 ↗
• MalfunctionSep 27, 2019Break; Break

  I RECEIVED FROM THE OPERATING ROOM MANAGER THE BROKEN DEVICES IN A BAG. NO FURTHER INFORMATION WAS RECEIVED. UPON REQUEST IT WAS CONFIRMED THAT THE PROCEDURES WERE SUCCESSFULLY COMPLETED. THE SURGERY DATE WAS DERIVED FROM THE STERI STICKER AND MIGHT NOT BE THE ACTUAL DATE AS IT CAN TAKE UP TO A DAY TO COMPLETE CLEANING AND STERILISATION. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: ABOUT 5MIN. ACTION TAKEN WHEN EVENT OCCURRED? SCREWS REPLACED WITH NEW SCREWS. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131242 ↗
• MalfunctionSep 27, 2019Break; Break

  I RECEIVED FROM THE OR MANAGER THE BROKEN DEVICES IN A BAG. NO FURTHER INFORMATION WAS RECEIVED. UPON REQUEST IT WAS CONFIRMED THAT THE PROCEDURES WERE SUCCESSFULLY COMPLETED. THE SURGERY DATE WAS DERIVED FROM THE STERI STICKER AND MIGHT NOT BE THE ACTUAL DATE AS IT CAN TAKE UP TO A DAY TO COMPLETE CLEANING AND STERILISATION. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: ABOUT 5MIN. ACTION TAKEN WHEN EVENT OCCURRED? SCREWS REPLACED WITH NEW SCREWS. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131093 ↗
• InjuryFeb 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT,DURING COMPRESSION MANOUVERS, THE MONOAXIAL SCREW (THE MOST PROXIMAL) TWISTED. THE ROD WAS ALREADY INSERTED, SO THE PROBLEM WAS NOT RELATED WITH THE REDUCTION OF THE SCREW; THAT WAS EASILY DONE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? REDUCTION OF THE COMPRESSION APPLIED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, OTHER INFORMATION: APPARENTLY THE SCREW DID NOT BREAK, BUT COULD BE A POSSIBILITY. THE PATIENT WILL BE CLOSELY SUPERVISED, PATIENT STATUS/OUTCOME/CONSEQUENCES? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(4), DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available

  MAUDE report 8371591 ↗