VIPER 286725225Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705034214320), received between Nov 1, 2019 and Jan 13, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE CUSTOMER COMPLAIN THAT THE THREE-PART ARTICLE CAN NO LONGER BE PROPERLY ASSEMBLED/ASSEMBLED. NO PATIENT INVOLVED. THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16160028 ↗
• MalfunctionJul 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE INSERTER TWISTED OFF; SCREW EXTENSION SLEEVE COULD NOT BE FIXED TO THE SCREW. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960941 ↗
• MalfunctionNov 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, DURING INSERTION, THE SLEEVE LOOSENED SEVERAL TIMES FROM THE VIPER SCREW AND WAS REPLACED BY ANOTHER SLEEVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A VIPER 2 SYSTEM MULTI-PIECE SCREW EXTENSION CLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751099 ↗
• MalfunctionNov 3, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, INTRAOPERATIVELY THE INSTRUMENT FRACTURED AT THE WELDING SEAM WHEN INSERTING THE CAGE. NO FRAGMENT REMAINED IN THE PATIENT. A SECOND INSTRUMENT WAS USED FOR THE FINAL INSERTION OF THE CAGE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT HARM. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM MULTI-PIECE SCREW EXTENSION CLOSED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749338 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690799 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW, AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ) THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690788 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690786 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690784 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690782 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690780 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW, AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690768 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MINIMALLY INVASIVE SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2020, THE VIPER 2 TOWER FAILED TO GRIP ONTO THE TULIP OF THE SCREW AND CAME OFF DURING THE SURGERY. IT WAS REPLACED WITH ANOTHER ONE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) VIPER2 SCREW EXT, MULTI PIECE. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690571 ↗
• MalfunctionFeb 13, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ONE "WING" BROKE ON THE INNER COMPONENT OF THE INSTRUMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9707012 ↗
• MalfunctionNov 1, 2019Break; Break

  THERE IS A FISSURE IN THE INSTRUMENT. SEEN IN CSSD. PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT SURGERY DELAY. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265999 ↗
• MalfunctionNov 1, 2019Break; Break

  THERE IS A FISSURE IN THE INSTRUMENT. SEEN IN CSSD. PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT SURGERY DELAY. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265973 ↗