VIPER PRIME 286750210SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034507828), received between May 12, 2022 and Jan 8, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: ADJACENT SEGMENT PATHOLOGY, IMPLANT FAILURE. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VIPER PRIME NAVIGATION INSTRUMENT, VIPER /OTHER AND VIPER CFX FENESTRATED PRODUCTS. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18463489 ↗
• MalfunctionSep 8, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: ON (B)(6) 2022, IT WAS REPORTED THAT THE STYLET WAS BENT DURING INITIAL INSERTION. THERE WAS NO SURGICAL DELAY. A SIMILAR INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT INVOLVES ONE VIPER PRIME NAVIGATION STYLET. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378767 ↗
• 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 THE (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

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

  MAUDE report 14377388 ↗