VIPER PRIME 286750020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034507576), received between Feb 15, 2021 and Mar 3, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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. 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 7 most recent of 7 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 DIALATOR (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 24499990 ↗
• MalfunctionJun 6, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A CHIP IS LOCATED INSIDE THE INSTRUMENT AND CANNOT BE REMOVED. IT LOOKS AS IF THE CHIP REMAINED FROM THE MILLING DURING MANUFACTURING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159359 ↗
• MalfunctionJan 24, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CLEANING PROCESS IT WAS MENTIONED THAT THERE WAS A RING ON THE INSIDE OF THE SLEEVE WHICH MEANS THAT THE INSTRUMENT NO LONGER FIT THROUGH IT. THERE WAS NO PATIENT HARM, AND NO DELAY IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE VIPER PRIME DILATOR SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234810 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) (L2-4) FOR SPINAL STENOSIS WHEN THE SURGEON TRIED TO REATTACH THE DILATOR TO THE SLEEVE, THE DILATOR ADVANCED ONLY HALFWAY THROUGH THE SLEEVE. AS PER THE SURGICAL TECHNIQUE, THE DILATOR WAS RELEASED FROM THE DILATOR SLEEVE AFTER THE SLEEVE CONTACTED THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING THE OTHER IN THE SLEEVE SET. AFTER THE SURGERY, THE DISPLACEMENT OF THE METAL RING INSIDE THE SLEEVE WAS VISUALLY CONFIRMED. THIS REPORT INVOLVES ONE (1) VIPER PRIME DILATOR SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778243 ↗
• MalfunctionSep 24, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT WHILE USING THE DILATATOR OF THE VIPER PRIME DILATOR SLEEVE, A SNAP RING WAS LOOSENED. ANOTHER DEVICE WAS READILY AVAILABLE SO THERE WAS NO SURGERY DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. VISUAL INSPECTION OF THE COMPLAINT DEVICE AND REVIEW OF THE PROVIDE IMAGE SHOWED THAT THE OPENED SNAP RING WAS NOT ATTACHED TO THE CANNULA AND WAS DEFORMED. THIS REPORT IS FOR A VIPER PRIME DILATOR SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526753 ↗
• MalfunctionSep 16, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING DEMO TRAINING THE METAL SPRING COMPONENT CAME LOOSE AND THE INSTRUMENT CAN NO LONGER BE USED. THIS REPORT INVOLVES ONE (1) VIPER PRIME DILATOR SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482432 ↗
• MalfunctionFeb 15, 2021Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING EDUCATION WORKSHOP WITH VIPER PRIME, WE NOTICED THAT THE SPRING IN THE LUMEN OF THE VIPER PRIME DILATOR SLEEVE, ART.NR 286750020 WAS LOOSE INSIDE. THEREFORE CAN THE INSTRUMENT NOT WORK PROPERLY, AND IT MIGHT ALSO BE A RISK THAT THE SPRING WILL GET LOOSE IN THE PATIENT DURING SURGERY AND CAUSE PROBLEMS OR INJURY. THIS WAS AN EDUCATION BEFORE PLANNED SURGERY, THEREFOR THERE WAS NO PATIENT INVOLVED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNK - PLATES. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330324 ↗