VIPER 186720535Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034125619), received between Apr 13, 2021 and Feb 11, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE DOING THE FINAL LOCK, AFTER THE MANEUVER OVERRIDE, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS WAS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT/DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517753 ↗
• MalfunctionFeb 11, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE DOING THE FINAL LOCK, AFTER THE MANEUVER OVERRIDE, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS WAS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT/DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517732 ↗
• MalfunctionFeb 11, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE DOING THE FINAL LOCK, AFTER THE MANEUVER OVERRIDE, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS WAS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT/DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517716 ↗
• MalfunctionDec 15, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) VIPER UNI SCREW 5 X 35MM TI. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014268 ↗
• MalfunctionDec 15, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) VIPER UNI SCREW 5X35MM TI. THIS REPORT IS 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014237 ↗
• MalfunctionDec 15, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TORQUE DEVICE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) VIPER UNI SCREW 5X35MM TI. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13013395 ↗
• MalfunctionDec 7, 2021Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE DOING THE FINAL LOCK, AFTER THE DEROGATION MANEUVER, THE SURGEON FOUND THAT THE ROD WAS NOT TIGHTLY BLOCKED INTO THE UNIPLANAR SCREW HEADS. THIS IN COMPARISON WITH THE UPPER AND LOWER POLY AXIAL SCREWS WITH THE FIXATION TO THE ROD WAS VERY SOLID. WITH THE UNIPLANAR SCREWS, ONE COULD CLEARLY SEE AN UNEXPECTED MEDIO-LATERAL MOVEMENT / DEGREE OF FREEDOM DESPITE AN AD-HOC TIGHTENING WITH THE TORQUE HANDLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) VIPER UNI SCREW 5X35MM TI. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953849 ↗
• InjuryApr 13, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT UNIPLANAR SCREWS WERE REMOVED FROM THE PATIENT THAT FOUND TO BE SLIGHTLY BENT AT COLLAR LEVEL, IT WAS PERPENDICULAR FROM THE NATURAL SCREWHEAD AXIS. IT WAS ALSO IMPORTANT TO NOTE: THE ABLATION OF THESE SCREWS HAS NO RELATIONSHIP, NOR REASONS, WITH THE BENDING ISSUE ANNOUNCED IN THIS COMPLAINT. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED UNIPLANAR SCREW 5.5 X 5.0 X 35MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11655791 ↗