VIPER 286710116Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034213828), received between Nov 30, 2020 and Jan 2, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: CUSTOMER IS COMPLAINING THE INSTRUMENT AS THE GREEN MATERIAL COMES OFF. ISSUE WAS DETECTED DURING A ROUTINE INSPECTION/REPROCESSING PROCEDURE. THIS REPORT IS FOR ONE (1) CANNULATED PEDICLE PROBE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425548 ↗
• MalfunctionJul 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, YELLOW STAINS DEVELOPED ON THE DEVICES. THIS WAS DISCOVERED ON THE INSTRUMENTS AFTER WASHING AND STERILIZATION DURING INSPECTION. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) VIPER 2 SYSTEM CANNULATED STRAIGHT PEDICLE PROBE 5.5 30-60MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239943 ↗
• MalfunctionJul 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, YELLOW STAINS DEVELOPED ON THE DEVICES. THIS WAS DISCOVERED ON THE INSTRUMENTS AFTER WASHING AND STERILIZATION DURING INSPECTION. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER 2 SYSTEM CANNULATED STRAIGHT PEDICLE PROBE 5.5 30-60MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239942 ↗
• MalfunctionNov 30, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF THE CANNULATED PEDICLE PROBES ARE WORN AND CRACKED. THE INNER AWL IS BLUNTED FROM USE. ONE OF THE PROBES ARE ALSO VISIBLY BENT. THESE ARE SEEMINGLY A RESULT OF WEAR-AND-TEAR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED PEDICLE PROBE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10922544 ↗
• MalfunctionNov 30, 2020Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIPS OF THE CANNULATED PEDICLE PROBES ARE WORN AND CRACKED. THE INNER AWL IS BLUNTED FROM USE. ONE OF THE PROBES ARE ALSO VISIBLY BENT. THESE ARE SEEMINGLY A RESULT OF WEAR-AND-TEAR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED PEDICLE PROBE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10922505 ↗