VIPER PRIME 286750042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034507651), received between Nov 16, 2020 and Mar 27, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE DRIVER TIP WAS UNABLE TO SECURE TO THE HANDLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR A VIPER PRIME NAVIGATION INSERTER DRIVE TUBE. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618366 ↗
• MalfunctionMar 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE DRIVER TIP WAS UNABLE TO SECURE TO THE HANDLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME NAVIGATION INSERTER DRIVE TUBE. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618364 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A TEST PHASE WITH THE PERCUTANEOUS STABILIZATION SYSTEM "VIPER PRIME" IN COMBINATION WITH THE NAVIGATION SYSTEM FROM BRAINLAB IN THE CONTEXT OF A PATIENT-SPECIFIC PATIENT INDICATION WAS OCCURRING AT (B)(6). VARIOUS ORTHOKITS OF THE NAVIGABLE VIPER PRIME SYSTEM (INSTRUMENTS AND IMPLANTS) WERE STATIONED ON SITE. INSTRUCTION OF THE INSTRUMENTS WAS CONDUCTED ON SITE. DUE TO THE COMPLEXITY OF THE NAVIGATED VIPER PRIME SETTINGS, IT WAS ALSO VERBALLY AGREED WITH THE USERS THAT ANY OPERATIONS WITH THIS NAVIGABLE VIPER PRIME SET OF INSTRUMENTS MAY ONLY BE CARRIED OUT BY A SURGICAL ASSISTANT OR BY A REPRESENTATIVE. UP TO (B)(6) 2021, ABOUT 2-3 ACCOMPANIED SURGERIES OF THIS TYPE WERE SUCCESSFULLY CARRIED OUT BY DR (B)(6) AND/OR PRIMARY (B)(6). A SURGERY WAS PLANNED FOR (B)(6) 2021. NO OBJECTION TO CARRYING OUT SUCH SURGERIES EXCLUSIVELY WITH A SURGICAL ACCOMPANIMENT FROM A SYNTHES REPRESENTATIVE WAS JUSTIFIED IN SUCH A WAY THAT THE USERS ARE SUFFICIENTLY FAMILIAR WITH THIS SYSTEM AND THAT ALL IMPLANTS ARE COMPLETE. DR. (B)(6) ON (B)(6) 2022 REPORTED OVER THE PHONE ABOUT A PATIENT SPECIFIC CASE WITH THE PERC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14380069 ↗
• MalfunctionNov 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  ONLY THE SHAFT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10843250 ↗