VIPER 186727880Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034282855), received between Jun 11, 2019 and Nov 25, 2020 — classified as 2 injuries.

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.

• InjuryNov 25, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TULIP BROKE OFF OF THE SCREW. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES: UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN SETSCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 80MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10904733 ↗
• InjuryJun 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE CORTICAL FIX FENESTRATED SCREW MIS TI CFX FEN POLY 8X80 WAS BEING INSERTED INTO THE S2-ALAR POSITION AND BECAME TIGHT. AT THE POINT OF NO POSSIBLE FURTHER FORWARD MOMENTUM, THE DECISION WAS TAKEN TO REMOVE THE SCREW AND UTILIZE A SMALLER DIAMETER SCREW. THE SCREW CAME DETACHED FROM THE SCREW INSERTION INSTRUMENT (286725300) AS THE TORQUE REQUIRED WAS TOO LARGE. MANY ALTERNATIVE INSTRUMENTS WERE USED TO TRY AND REMOVE THE SCREW WITH COUNTERCLOCKWISE ROTATIONS HOWEVER THEY DIDN¿T WORK. DURING THIS SCREW REMOVAL ATTEMPT, A SCREW MIS TI CFX FEN POLY 7X70 PLACED INTRADISCALLY THOUGH S1-L5 WAS TO BE REVERSED SLIGHTLY IN ORDER TO GAIN FURTHER ROOM AND LEVERAGE ON MIS TI CFX FEN POLY 8X80. AT THE FIRST ATTEMPT TO REVERSE THIS SCREW, THE POLYAXIAL HEAD EVENTUALLY PULLED OVER THE HEAD OF THE SHANK OF THE SCREW WHICH HAD FATIGUED AND BROKEN. THERE WAS SIGNIFICANT PROUDNESS OF THE SCREW SHANK AND THEREFORE THERE WAS SIGNIFICANT TIME TAKEN TO TRY TO REMOVE THIS. EVENTUALLY, SEVERAL BURRS WERE USED TO ¿CUT THROUGH¿ THE SCREW AND GET IT FLUSH TO THE PATIENTS BONE WHERE IT WAS LEFT IN SITU. THERE WAS A SURGICAL DELAY ON AN UNKNO

  Patient problems: No Code Available

  MAUDE report 8688699 ↗