VIPER PRIME 286750082Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034507729), received between Dec 31, 2019 and Mar 7, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING A PLIF FOR THE LUMBAR STENOSIS BEFORE STERILIZATION, STEIN WAS FOUND IN THE HOLLOW PART OF THE DEVICES. THE DEVICES WERE DELIVERED ON THE OPERATION DAY, AND THE SURGEON DETERMINED THAT IT WOULD TAKE TIME TO CLEAN. THEREFORE, OTHER SAME DEVICES WERE USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VIPER PRIME COMP DRIVER LEG. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496513 ↗
• MalfunctionJul 19, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PROCEDURE FOR PERCUTANEOUS POSTERIOR THORACOLUMBAR FUSION, THE DRIVER LEG WAS UNABLE TO BE DETACHED FROM AN UNKNOWN SCREW. THE DRIVER LEG WAS MOUNTED ONTO THE COMPRESSOR DRIVER AND APPLIED COMPRESSION TO TH11. A DRIVER SOLID LEG AS APPLIED TO TH12 FOR COMPRESSION AS WELL. AFTER THE COMPRESSION WAS APPLIED, WHEN THE SURGEON TRIED TO DETACH THE DRIVER LEG, THEY COULD NOT. THE DRIVER LEG AND SCREW WERE STUCK TOGETHER TIGHTLY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A VIPER PRIME COMPRESSOR DRIVER LEG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055208 ↗
• MalfunctionMar 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN UNKNOWN PROCEDURE IT WAS DIFFICULT TO DETACH THE DRIVER LEG (286735400) FROM THE IMPLANTS. THE PROCEDURE WAS DELAYED. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE VIPER PRIME COMP DRIVER LEG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848639 ↗
• InjuryDec 31, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) TO TREAT A SPINAL CANAL STENOSIS THAT AFTER INSERTING THE DRIVER LEG (286750082), THE SURGEON PUT COMPRESSION AND TRIED TO REMOVE IT FROM THE TABS BUT THE DRIVER LEG WAS NOT ABLE TO BE REMOVED. THE SURGEON BROKE OFF THE TABS TO SUCCESSFULLY REMOVE THE DRIVER LEG BREAKING THE SCREW'S TABS. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30-MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE VIPER PRIME COMP DRIVER LEG. THIS IS REPORT 2 OF 2 FOR PC-(B)(4).

  Patient problems: No Code Available

  MAUDE report 9535720 ↗