VIPER PRIME 286750010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034507569), received between Jun 21, 2021 and Mar 3, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE THIN INNER RING OF THE DILATOR DETACHED FROM THE DILATATOR (VIPER PRIME) WHEN THE SCREWDRIVER WAS PULLED OUT AFTER IMPLANTATION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499991 ↗
• MalfunctionFeb 6, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT A RING WAS LOOSENED WHILE INSERTING THE SCREW THROUGH THE DILATOR. IT WAS NOTICED ON XRAY AND REMOVED FROM THE PATIENT! THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322880 ↗
• MalfunctionSep 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT DURING DILATION, WHEN REMOVING THE INTERNAL PART, THE RETAINING RING IN THE DEVICE CAME OFF. THE PIECE CONTINUED TO BE USED WITHOUT THE RING, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS OR HARM TO THE PATIENT. THIS REPORT INVOLVES ONE VIPER PRIME DILATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409845 ↗
• MalfunctionJul 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION, IT WAS NOTICED A CRACK AT THE TIP (TRANSITION FROM PLASTIC TO METAL). NO SURGERY IMPACT, NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) VIPER PRIME DILATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118036 ↗
• MalfunctionJun 21, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN INSPECTION, A HAIRLINE FRACTURE WAS IDENTIFIED ON THE INSTRUMENT. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR (1) VIPER PRIME DILATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032095 ↗