VIPER 186715640Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034122342), received between Aug 5, 2019 and Feb 23, 2022 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SCOLIOSIS FIXATION RANGING FROM T3-L1 ON (B)(6) 2022. THE LAST 2 CAUDAL SCREWS, ON BOTH SIDES, FOUND THEIR RESPECTIVE SETSCREWS LOOSENED. SURGEON DISCOVERED UNSTABLE MONTAGE AND METALLOSIS. FOUR SCREWS WERE REPLACED IN TOTAL AND THE FIXATION WAS EXTENDED BY ONE LEVEL CAUDALLY. THIS REPORT IS FOR AN UNKNOWN VIPER SCREW. THIS IS REPORT 7 OF 9 FOR (B)(4).

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

  MAUDE report 13584320 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SCOLIOSIS FIXATION RANGING FROM T3-L1 ON (B)(6) 2022. THE LAST 2 CAUDAL SCREWS, ON BOTH SIDES, FOUND THEIR RESPECTIVE SETSCREWS LOOSENED. SURGEON DISCOVERED UNSTABLE MONTAGE AND METALLOSIS. FOUR SCREWS WERE REPLACED IN TOTAL AND THE FIXATION WAS EXTENDED BY ONE LEVEL CAUDALLY. THIS REPORT IS FOR AN UNKNOWN VIPER SCREW. THIS IS REPORT 6 OF 9 FOR (B)(4).

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

  MAUDE report 13584314 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SCOLIOSIS FIXATION RANGING FROM T3-L1 ON (B)(6) 2022. THE LAST 2 CAUDAL SCREWS, ON BOTH SIDES, FOUND THEIR RESPECTIVE SETSCREWS LOOSENED. SURGEON DISCOVERED UNSTABLE MONTAGE AND METALLOSIS. FOUR SCREWS WERE REPLACED IN TOTAL AND THE FIXATION WAS EXTENDED BY ONE LEVEL CAUDALLY. THIS REPORT IS FOR A MIS CANN POLY SCW 6X40MM,TI. THIS IS REPORT 1 OF 9 FOR (B)(4).

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

  MAUDE report 13584006 ↗
• InjuryOct 19, 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 ON (B)(6) 2021, THE PATIENT HAD SUFFERED FROM ADJACENT CENTRUM DISORDER. THE PATIENT SCHEDULED TO UNDERGO A PLIF REVISION PROCEDURE (L4/5). THE PRIMARY PLIF(5/S) WAS PERFORMED ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 6X40MM,TI. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12661123 ↗
• InjuryOct 19, 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 ON (B)(6) 2021, THE PATIENT HAD SUFFERED FROM ADJACENT CENTRUM DISORDER. THE PATIENT SCHEDULED TO UNDERGO A PLIF REVISION PROCEDURE (L4/5). THE PRIMARY PLIF(5/S) WAS PERFORMED ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 6X40MM,TI. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12661105 ↗
• InjuryOct 19, 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 ON (B)(6) 2021, THE PATIENT HAD SUFFERED FROM ADJACENT CENTRUM DISORDER. THE PATIENT SCHEDULED TO UNDERGO A PLIF REVISION PROCEDURE (L4/5). THE PRIMARY PLIF(5/S) WAS PERFORMED ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR (1) MIS CANN POLY SCW 6X40MM,TI. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12661086 ↗
• InjuryOct 19, 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 ON (B)(6) 2021, THE PATIENT HAD SUFFERED FROM ADJACENT CENTRUM DISORDER. THE PATIENT SCHEDULED TO UNDERGO A PLIF REVISION PROCEDURE (L4/5). THE PRIMARY PLIF(5/S) WAS PERFORMED ON (B)(6) 2012. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 6X40MM,TI. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Osteolysis

  MAUDE report 12661078 ↗
• MalfunctionSep 30, 2021Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT PART OF THE SCREW FROZE IN THE SCREW NEST. THERE WERE NO CONSEQUENCES FOR THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554946 ↗
• InjuryMar 8, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 6 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11436502 ↗
• InjuryMar 8, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 7 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11436271 ↗
• InjuryMar 8, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 5 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11436231 ↗
• InjuryMar 8, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 4 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11436008 ↗
• InjuryMar 8, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY FOLLOWING A SCOLIOSIS FIXATION PERFORMED IN 2018 DUE TO SCREW PULL-OUT. THE PROCEDURE WAS PERFORMED BY THE SAME SURGEON IN THE SAME HOSPITAL. DURING THIS REVISION, THE SURGEON REPORTED THAT PREVIOUSLY PLACED INNIES WERE FOUND TO BE LOOSE IN SOME SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A VIPER SCREW. THIS IS REPORT 1 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

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

  MAUDE report 11435956 ↗
• InjurySep 20, 2019Break; Break

  PHYSICIAN REPORTED THAT PRODUCT HAS BEEN REMOVED BECAUSE HAD BEEN BROKEN DURING PREVIOUS PROCEDURE. PREVIOUS PROCEDURE WAS ON (B)(6) 2018. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MIS CANN POLY SCW 6 X 40 MM,TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9098353 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THERE WAS NO REPORTED OR IDENTIFIED MALFUNCTION OF THE DEVICE.

  Patient problems: No Code Available; Pain

  MAUDE report 8861677 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THERE WAS NO REPORTED OR IDENTIFIED MALFUNCTION OF THE DEVICE.

  Patient problems: No Code Available; Pain

  MAUDE report 8861610 ↗