VIPER 179706880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034266442), received between Nov 24, 2020 and Feb 23, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) VIPER SCREWS BROKE ABOUT 2 CM BELOW THE SCREW HEAD. THEY HAD TO BE REPLACED DURING A REVISION SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 5.5 8 X 80MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11365672 ↗
• InjuryFeb 23, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO (2) VIPER SCREWS BROKE ABOUT 2 CM BELOW THE SCREW HEAD. THEY HAD TO BE REPLACED DURING A REVISION SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL FULLY THREADED SCREW 5.5 8 X 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11365664 ↗
• InjuryNov 24, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD LOOSENING OF SCREWS AND REQUIRED A RE-ARTHRODESIS. ALL SCREWS WERE SUCCESSFULLY REMOVED FROM LEFT/RIGHT - L3, L4, L5, S1, IL. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICES: EXPEDIUM 5.5MM TITANIUM RODS(PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2); 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # UNKNOWN, QUANTITY # 8); SINGLE-INNER SET SCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) VIPER T27 ILIAC SCREW 8X80, TI. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10891676 ↗
• InjuryNov 24, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD LOOSENING OF SCREWS AND REQUIRED A RE-ARTHRODESIS. ALL SCREWS WERE SUCCESSFULLY REMOVED FROM LEFT/RIGHT - L3, L4, L5, S1, IL. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICES: EXPEDIUM 5.5MM TITANIUM RODS(PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2). 5.5 EXP VERSE UNITIZED SET SCR (PART # 199721001, LOT # UNKNOWN, QUANTITY # 8). SINGLE-INNER SETSCREW (PART # 179702000, LOT # UNKNOWN, QUANTITY # 2). THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X40. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10889887 ↗