VIPER 186715645Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705034122359), received between Jul 10, 2018 and Sep 11, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionSep 11, 2025Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT DURING THE SURGERY, POLYAXIAL SCREW DOES NOT MATE WITH INSERTION DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031864 ↗
• MalfunctionJan 12, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18502608 ↗
• MalfunctionMar 30, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE VIPER SCREW HEAD THREAD BROKE. THERE WAS SURGICAL DELAY OF FIVE (5) MINUTES. THE BROKEN SCREW WAS REMOVED AND ANOTHER SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 45MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588478 ↗
• InjuryOct 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  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-160 MM (PART # 186789160, LOT # UNKNOWN, QUANTITY 1), VIPER2 STRAIGHT ROD-180 MM (PART # 186789180, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9152342 ↗
• InjuryOct 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  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 9152121 ↗
• InjuryJan 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ,AFTER FINAL TIGHTENING OF THE SINGLE INNER SETSCREW, THE ROD CAME OUT DAMAGING THE HEAD OF THE POLY SCREW AND THE SINGLE INNER SETSCREW. LATER 2 SINGLE INNER SETSCREWS WERE TRIED BUT THAT TOO GOT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243811 ↗
• InjuryJul 10, 2018Break; Break

  THE PATIENT GOT 4 SCREWS IMPLANTED ON L5-S1 TO TREAT A GRADE I SYMPTOMATIC ISTHMIC SPONDYLOLISTHESIS WHEN ADOLESCENT. AFTER SOME MONTHS, THE SEGMENT APPEARED AS FUSED ON SCANNER. HOWEVER PATIENT PRACTICES SKI JUMPS AT COMPETITION LEVEL AND FELT DISCOMFORT WITH THE IMPLANTS. ON RADIOGRAPHY PERFORMED LATER ON, ONE S1 SCREW APPEARED AS BROKEN AT THE LEVEL OF THE NECK OF THE SHANK (BOTTOM OF SCREW HEAD). UPON REMOVING IMPLANTS, BOTH S1 SCREW NECKS WERE BROKEN. SURGEON BELIEVES THIS IS A DUE TO THE EXTREME CONSTRAINTS THAT THE SKI JUMP SUPPOSED ON THE IMPLANTS. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:THE PATIENT WAS FEELING THE IMPLANTS AND THIS CREATED SOME DISCOMFORT. ACTION TAKEN FOR PROCEDURE: REMOVAL OF IMPLANTS. SURGEON DECIDED TO LEAVE THE BROKEN SHAFTS IN S1. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 7674228 ↗
• InjuryJul 10, 2018Break; Break

  THE PATIENT GOT 4 SCREWS IMPLANTED ON L5-S1 TO TREAT A GRADE I SYMPTOMATIC ISTHMIC SPONDYLOLISTHESIS WHEN ADOLESCENT. AFTER SOME MONTHS, THE SEGMENT APPEARED AS FUSED ON SCANNER. HOWEVER PATIENT PRACTICES SKI JUMPS AT COMPETITION LEVEL AND FELT DISCOMFORT WITH THE IMPLANTS. ON RADIOGRAPHY PERFORMED LATER ON, ONE S1 SCREW APPEARED AS BROKEN AT THE LEVEL OF THE NECK OF THE SHANK (BOTTOM OF SCREW HEAD). UPON REMOVING IMPLANTS, BOTH S1 SCREW NECKS WERE BROKEN. SURGEON BELIEVES THIS IS A DUE TO THE EXTREME CONSTRAINTS THAT THE SKI JUMP SUPPOSED ON THE IMPLANTS. PATIENT CONSEQUENCE?: YES. PATIENT CONSEQUENCE DESCRIPTION:THE PATIENT WAS FEELING THE IMPLANTS AND THIS CREATED SOME DISCOMFORT. ACTION TAKEN FOR PROCEDURE:REMOVAL OF IMPLANTS. SURGEON DECIDED TO LEAVE THE BROKEN SHAFTS IN S1. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Pain; Spinal Column Injury

  MAUDE report 7674184 ↗