VIPER 186727940Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034282886), received between Jul 14, 2020 and Jun 14, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSERTION THE SURGEON HAD DECLINED TAPPING PRIOR TO INSERTING THE SCREW. THE HEAD OF THE SCREW SNAPPED OFF AT THE SHANK. THE INSTRUMENTATION WERE ABLE TO REMOVE WITH FROM SPINE SCREW REMOVAL SET. SURGEON THEN TAPPED WITH AN 8.0 FOR AN 8.0MM DIAMETER SCREW. WHILE COMPLETING INSERTION OF THIS SCREW THE NAVIGATED T20 POLY SCREWDRIVER TIP BROKE OFF. THIS SCREW WAS IN THE CORRECT POSITION AT THE TIME OF THE DRIVER TIP FAILURE SO NO REPOSITIONING WAS NEEDED. ALSO THE SURGEON WAS ABLE TO REMOVE THE BROKEN TIP USING SUCTION. THE PATIENT WAS NOT HARMED IN THESE EVENTS. IT WAS FELT THESE BREAKAGES OCCURRED DUE TO THE PATIENTS HARD/DENSE SCLEROTIC BONE THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 9X40. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684497 ↗
• InjuryJul 14, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, UPON INSERTING A 9.0 X 40 MM CORTICAL SCREW INTO S1, IT APPEARED THAT THE SCREWDRIVER BECAME LOOSENED FROM THE SCREW HEAD. THE DRIVER WAS REMOVED AND IT WAS OBSERVED THAT THE TIP OF THE DRIVER SHEARED OFF. IT WAS THEN ATTEMPTED TO REMOVE THE SCREW FROM THE PATIENT BY USING VARIOUS KNOWN COMMON TECHNIQUES BUT IN DOING SO THE POLY HEAD OF THE SCREW CAME OFF OF THE HALF INSERTED SCREW. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE REMAINING SCREW BUT WERE UNSUCCESSFUL. THE TOP PORTION OF THE SCREW HEAD WAS BURRED/ CUT OFF TO ALLOW ROOM FOR THE ACCOMMODATION OF STEPS NEEDED TO FINISH THE CASE. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CORTICAL FIX FENESTRATED, 9.0 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10272405 ↗