VIPER PRIME 286750150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034529776), received between Aug 20, 2025 and Dec 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A POSTERIOR SPINAL FUSION(L4/5) PROCEDURE FOR SACRAL FRACTURE. DURING THE SURGERY, AFTER PLACING THE ALIGNMENT DEVICE ON THE SCREW, THE SURGEON CHECKED TO SEE IF THE OPEN CANNULA COULD PASS THROUGH, BUT THE OPEN CANNULA WOULD NOT GO THROUGH. THE SALES REP CHECKED THE ORIENTATION OF THE ALIGNMENT DEVICE SEVERAL TIMES AND REATTACHED IT, BUT IT STILL WOULD NOT GO THROUGH. THERE WAS NO PROBLEM WITH THE ORIENTATION OF THE SCREW, AND OF COURSE THE OPEN CANNULA WAS NOT BENT. THEREFORE, THE SURGEON TRIED CLEANING THE ALIGNMENT DEVICE WITH A GUIDE WIRE OUTSIDE THE OPERATING FIELD, AND ALTHOUGH THE GUIDE WIRE WENT THROUGH NORMALLY, THE OPEN CANNULA STILL WOULD NOT GO THROUGH. IT SEEMED THAT THE THICKER PART OF THE OPEN CANNULA WAS GETTING CAUGHT SOMEWHERE IN THE ALIGNMENT DEVICE, SO THE SURGEON REMOVED AND REINSERTED THE GUIDE WIRE TO CLEAN IT AGAIN, AND WHITE AND BLACK DEBRIS, SOME FOREIGN MATTER CAME OUT. IT'S POSSIBLE THAT CEMENT OR BLOOD FROM THE PREVIOUS OR EARLIER OPERATION HAD HARDENED AND STUCK TO THE INSIDE OF THE ALIGNMENT DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINS OF DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843643 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED FOR THORACOLUMBAR VERTEBRAE ON (B)(6), 2025. THE SURGEON INSERTED THE ALIGNMENT DEVICE AND ATTEMPTED TO ATTACH AN OPEN CANNULA TO INSERT CEMENT, BUT IT DID NOT PENETRATE DEEP ENOUGH, AND THE CEMENT COULD NOT BE INSERTED. IT APPEARS THAT A WHITE SUBSTANCE LIKE CEMENT CAME OUT DURING THE OPERATION, AND IT IS LIKELY THAT CEMENT HAD BEEN STUCK INSIDE. WHEN THE SURGEON CHECKED AFTER THE OPERATION, HE FOUND THAT THE OPEN CANNULA HAD INDEED NOT REACHED ITS SPECIFIED SETTING POSITION. USING ANOTHER ALIGNMENT GUIDE, THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851280 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED FOR THORACOLUMBAR VERTEBRAE ON (B)(6) 2025. THE SURGEON INSERTED THE ALIGNMENT DEVICE AND ATTEMPTED TO ATTACH AN OPEN CANNULA TO INSERT CEMENT, BUT IT DID NOT PENETRATE DEEP ENOUGH, AND THE CEMENT COULD NOT BE INSERTED. IT APPEARS THAT A WHITE SUBSTANCE LIKE CEMENT CAME OUT DURING THE OPERATION, AND IT IS LIKELY THAT CEMENT HAD BEEN STUCK INSIDE. WHEN THE SURGEON CHECKED AFTER THE OPERATION, HE FOUND THAT THE OPEN CANNULA HAD INDEED NOT REACHED ITS SPECIFIED SETTING POSITION. USING ANOTHER ALIGNMENT GUIDE, THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851084 ↗