VIPER PRIME 286750133NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034507804), received between Mar 22, 2018 and Apr 5, 2019 — classified as 2 injuries.

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

• InjuryApr 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE SPINE FUSION OF TH9-L3 FOR TH12 THORACIC VERTEBRAL FRACTURE WAS PERFORMED ON (B)(6) 2019 BY USING MEDTRONIC O-ARM STEALTH 7 AND VIPER PRIME NAVIGATION INSTRUMENT BY FOLLOWING THE INSTRUCTION MANUAL. STARTING FROM SUPERIOR FOR FIXATION, 6 SCREWS FOR TH9-11 WERE SUCCESSFULLY INSERTED INTO PEDICLE BY CONFIRMING WITH CT IMAGE. THEN, THE SURGEON CONTINUED TO INSERT THE SCREWS FOR REST OF THE POSITION. WHEN THE SURGEON HAS INSERTED THE 11TH SCREW FOR L3 LEFT, THE SURGEON FELT ABNORMALITY OF THE INSERTION OF THE SCREW WHICH MIGHT HAVE BEEN DEVIATED OF THE NAVIGATION. THEN, THE SURGEON CHECKED THE CONNECTION PART OF THE TRACKING UNIT AND RECOGNIZED THAT THE CONNECTION PART WAS LOOSENED. THUS, THE SURGEON TIGHTENED THE CONNECTION PART. AFTER THE SURGEON INSERTED THE LAST SCREW, WHEN THE SURGEON CHECKED THE CONDITION OF THE SCREW INSERTION BY CT IMAGE, THE SURGEON RECOGNIZED SCREWS OF L2 LEFT AND L3 LEFT WERE MISALIGNED TO INSIDE. THE UNILATERAL LAMINECTOMY WAS PERFORMED BECAUSE THE SURGEON SUSPECTED THE DAMAGE OF DURA. L3 LEFT SCREW CAUSED NO DAMAGE OF THE DURA SO THAT THE SURGEON REMOVED THE L3 LEFT SCREW AND REINFORCED BY NEOVEIL SHEET. HOWEVER, AS FOR L

  Patient problems: Injury; Nerve Damage; No Code Available

  MAUDE report 8489610 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN L5-S1 POSTERIOR LUMBAR INTERBODY FUSION USING OUR VIPER PRIME SYSTEM DR. ROB WHITMORE INSERTED MULTIPLE SCREWS UNDER NAVIGATION WITH THE MEDTRONIC STEALTH SYSTEM. THE MEDTRONIC SURETRACK CLAMP WAS ATTACHED SECURELY TO THE VIPER PRIME NAVIGATED SCREWDRIVER AND THEN MANUALLY CALIBRATED INTO THE STEALTH SYSTEM. THE NAVIGATION SEEMED TO BE WORKING WELL UNTIL THE 3RD SCREW WHEN THE SURGEON NOTICED THAT THE NAVIGATION WAS OFF. WE SPUN THE O-ARM WHICH CONFIRMED THAT 2 OF THE SCREWS WERE NOT WHERE HE INTENDED THEM TO BE. WE HAD TO CHANGE HIS TECHNIQUE AND INSTEAD USE A JAMSHIDI NEEDLE AND K-WIRES. THERE WAS NO HARM TO THE PATIENT BUT IT ADDED TIME TO THE PROCEDURE. PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE:THE SURGEON CHANGED HIS TECHNIQUE AND USED A NAVIGATED JAMSHIDI NEEDLE AND K-WIRES TO COMPLETE THE PROCEDURE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable

  MAUDE report 7361712 ↗