VIPER 186727845Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034282787), received between Jan 9, 2018 and Jan 23, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6). 2023, A SCREWDRIVER AND SCREW HEAD BROKE. THE BROKEN SCREWDRIVER PIECE WAS TAKEN OUT OF THE PATIENT. THE TULIP OF THE SCREW THAT BROKE OFF WAS TAKEN OUT. THE SHAFT OF THE SCREW REMAINED IN THE PATIENT. THERE WAS A REPORTED ONE HOUR OF SURGICAL DELAY. THIS REPORT IS FOR ONE MIS TI CFX FEN POLY 8X45 FOR(B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18562453 ↗
• InjuryJan 8, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT FAILURE, IMPLANT MALPOSITION, OTHER. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 45MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18463504 ↗
• MalfunctionJul 17, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A SCREW BROKE INTRAOPERATIVELY, AND THE TIP OF THE SCREWDRIVER ALSO BROKE OFF. THERE WAS NO PATIENT HARM AND NO DELAY TO SURGERY. THIS REPORT INVOLVES ONE VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 45MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331767 ↗
• MalfunctionNov 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN SPINAL PROCEDURE, TWO (2) POLYAXIAL SCREWS BROKE DURING FINAL INSERTION. THE SCREW HEADS DETACHED FROM THE SHAFTS. THE SCREWS WERE REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO REPLACEMENT SCREWS IN THE SAME POSITION WITHOUT ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THIS REPORT IS FOR ONE (1) VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 45MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12728746 ↗
• MalfunctionOct 28, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A L2-4 LATERAL INTERBODY FUSION AND L1-S1 POSTERIOR INSTRUMENTED FUSION PROCEDURE ON (B)(6) 2020. DURING THE PROCEDURE, WHEN INSERTING A 8X45 CFX SCREWS INTO ONE OF THE S1 PEDICLE THE SCREW WAS SQUEAKING ON INSERTION, AND IT WAS NOT A SOUND THAT IS TYPICALLY HEARD. CONSEQUENTLY WHEN REMOVING THE DRIVER THE WHOLE HEAD CAME AWAY STILL ATTACHED TO THE DRIVER WITH THE SCREW SHAFT REMAINING INSITU. AS THE SHAFT WAS STILL INTACT SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT WITH MINIMAL DAMAGE, AND ANOTHER SCREW WAS INSERTED. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES DUE TO REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ). THIS REPORT IS FOR ONE (1) MIS TI CFX FEN POLY 8X45 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748990 ↗
• InjuryFeb 14, 2018Break; Break

  LOOSENING OF SCREW HEAD AT THE AREA L2 ¿ L4 POSTOPERATIVELY. REVISIONSURGERY WITH IMPLANT REMOVAL AND RESPONDYLODESE L2/L4 (VIPER CEMENT AUGMENTED). SURGEON: PROF. (B)(6). PATIENT (B)(6).

  Patient problems: Not Applicable; Spinal Column Injury

  MAUDE report 7271155 ↗
• MalfunctionJan 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS WAS A MIS PROCEDURE. VIPER CFX SCREW HEAD DISLOCATED WHEN TRYING TO PERSUADE THE ROD USING VIPER 3D. (INNER PART OF SCREW HEAD GOT LOOSENED) SCREW HAD TO BE REMOVED AND REPLACED. PATIENT CONSEQUENCE? :NO IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177482 ↗