VIPER 186727755Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034282695), received between Sep 14, 2017 and Feb 10, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT MIS TI CFX FEN POLY 7X50 AND MIS TI CFX FEN POLY 7X55 WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A POSTERIOR SPINAL FUSION PROCEDURE. THE REPORTED FAILURE INVOLVED BOTH SCREWS BREAKING INTO TWO OR MORE PIECES INTRAOPERATIVELY, WITH THE TULIP TORN DOWN AND SCREW SHANKS UNABLE TO BE REMOVED. AS A RESULT, FRAGMENTS REMAINED EMBEDDED WITHIN THE PATIENT, AND THE SURGERY WAS PROLONGED BY 30 MINUTES. THE PROCEDURE WAS ULTIMATELY COMPLETED, BUT ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED DUE TO THE RETAINED SCREW SHAFTS. BOTH DEVICES ARE IDENTIFIED AS IMPLANTS AND HAVE REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24303378 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: POSTOPERATIVE INFECTION SUPERFICIAL COMPLICATION TIME/INTERVENTION. REPEAT SURGERY THIS IS FOR DEPUY SYNTHES SPINE VIPER /OTHER AND VIPER CFX FENESTRATED (MIS TI CFX FEN POLY 7X55 (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 18447341 ↗
• MalfunctionApr 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING SCREW INSERTION THE TIP OF SCREW DRIVER BROKE AND REMAINED STUCK IN THE SCREW HEAD. SCREW HAD TO BE REMOVED AND REPLACED. WE USED A ROD AND A SET CAP TO BLOCK THE SCREW HEAD AND REMOVED THE ASSEMBLY VIA ROD HOLDER. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 10 MINUTES. THERE IS NO INDICATION THAT THE DELAY RESULTED IN ANY IMPACT TO THE EXPECTED SURGICAL OUTCOME. USING ADDITIONAL INSTRUMENTATION, THE SCREW, WITH THE BROKEN FRAGMENT IN ITS HEAD, WAS EXPLANTED, AND THE PROCEDURE COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN RODS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) UNKNOWN SCREWS THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833820 ↗
• InjuryDec 17, 2020Break; Device Slipped; Break; Device Slipped

  THE BROKEN TIP OF THE SCREW REMAINS IN THE PATIENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11028275 ↗
• MalfunctionMay 13, 2020Break; Break

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED REPLACING SCREW WITH THE SAME SIZE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10053806 ↗
• MalfunctionSep 14, 2017Material Separation; Material Separation

  THE CFX SCREW WAS INSERTED BY SURGEON PERCUTANEOUSLY. THE SCREW HEAD SLIGHTLY TOO CLOSE TO THE SCLEROTIC BONE, SO THEY SAT TOO DEEP AND THE SCREW WAS NOT MORE POLY-AXIAL. WHILE SCREW OUT THE SCREW, THE SCREW HEAD HAS LOOSEN FROM SCREW SHAFT. THE INNER PART OF SCREW HEAD COULD ONLY RECOVERED IN CRUMBLED ITEMS AND WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864180 ↗