VIPER 186770045Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034129679), received between Nov 26, 2019 and Oct 23, 2025 — classified as 9 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POSTERIOR FUSION (L2-ILIAC BONE) WAS PERFORMED ON (B)(6) 2021. AFTER THE SURGERY, AN ADJACENT SEGMENT DISEASE WAS CONFIRMED AND THE REMOVAL SURGERY AND PLIF (L1-2) WAS PERFORMED ON (B)(6) 2025. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT CAPTURES THE FIRST PROCEDURE AND ITS CAUSE. THE REMOVAL PROCEDURE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 23369551 ↗
• InjuryJun 21, 2022Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A REVISION PROCEDURE, TWO VIPER PRIME SCREWS WERE REPLACED AS THE DISTAL TIPS BOTH BROKE. THIS REPORT IS FOR A VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14753939 ↗
• InjuryJun 21, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A REVISION PROCEDURE, TWO VIPER PRIME SCREWS WERE REPLACED AS THE DISTAL TIPS BOTH BROKE. THIS REPORT IS FOR A VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14753922 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600480 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600467 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR 1 VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600453 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600409 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600394 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A PRIMARY PLIF (L3/4/5) PERFORMED ON (B)(6) 2015. ON AN UNKNOWN DATE IT WAS FOUND THAT THE PATIENT HAD SUFFERED FROM ADJACENT DEGENERATIVE SCOLIOSIS. ON (B)(6) 2021 THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE (INTERBODY FUSION AT L2/3). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 12600355 ↗
• MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SPINAL FIXATION SURGERY ON (B)(6) 2019, THE SCREWDRIVER LOST CONNECTION TO THE IMPLANT DURING INSERTION OF THE IMPLANT. REINSERTION OF THE SCREWDRIVER WAS NOT POSSIBLE AND AFTER SOME MANIPULATION THE SURGEON MANAGED TO REMOVE THE IMPLANT AGAIN. ONCE THE IMPLANT WAS REMOVED THE SURGEON NOTICED THAT THE INNER-BUSHING IN THE SCREWHEAD HAD COME LOOSE AND WAS FREE-FLOATING IN THE SCREWHEAD (THIS BUSHING LOCKS THE POLYAXIALITY WHEN THE SETSCREW IS TIGHTENED). THE IMPLANT WAS REPLACED WITH ANOTHER SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO HARM WAS CAUSED TO THE PATIENT. THE SURGERY TIME WAS LENGTHENED FOR APPROXIMATELY TEN (10) MINUTES, BUT SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377928 ↗