VIPER 179704890Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034265742), received between Sep 18, 2017 and Jul 11, 2024 — classified as 2 injuries, 3 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2024Break; Compatibility Problem; Break; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A TIRSF (S2) FOR PELVIC FRACTURE ON (B)(6) 2024. IN THE SURGERY, THE SURGEON INSERTED THE S2AI IN THE LEFT AND RIGHT AND ATTEMPTED ROD-SET SCREW FUSION. AFTER THE SET SCREW WAS INSERTED, THE SET SCREW AND THE HEAD OF THE SCREW WAS DAMAGED WHEN THE SET SCREW WAS REMOVED DUE TO FAILURE TO APPLY FINAL TORQUE. SINCE FASTENING BECAME DIFFICULT, A NEW SCREW OF THE SAME SIZE WAS REINSERTED TO COMPLETE THE ROD SET SCREW FUSION. SOME BURRS FELL INTO THE BODY, BUT ALL WERE REMOVED AND FLUOROSCOPY WAS USED TO CONFIRM THAT NO DEBRIS REMAINED IN THE BODY. AFTER THOROUGH CLEANING, THE WOUND WAS CLOSED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. PATIENT WAS LISTED AS STABLE. THIS REPORT IS FOR ONE VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725822 ↗
• InjuryNov 21, 2023Device Slipped; Device Slipped

  PATIENT HAS CLAIMED SYMPTOM, AND THE SURGEON DISCOVERED THE SET SCREW HAS LOOSENED.

  Patient problems: Insufficient Information

  MAUDE report 18184116 ↗
• InjuryDec 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISENGAGEMENT HAPPENED ON BOTH SIDES (LEFT AND RIGHT OF PATIENT CONSTRUCT) AND IN BOTH CASES ON AT LEAST TWO SCREWS. ON THE RIGHT SIDE THE TOWERS DISENGAGED FROM THE L3 SCREW AND THE L5 SCREW. ON THE LEFT SIDE THE TOWER CAME AWAY FROM THE SAI SCREW. THE ROD WAS UNABLE TO ENGAGE WITH THE L4 SCREW ON THE LEFT SIDE AND EVENTUALLY THIS WAS EXPLANTED TOWARDS THE END OF THE PROCEDURE AND THIS LEVEL WAS SKIPPED ON THE LEFT SIDE. THE ROD WAS JUST SITTING TOO FAR OFF THE HEAD OF THE SCREW TO BE ABLE TO GET THE REDUCTION INSTRUMENTS TO ENGAGE THERE THREADS AND I DON¿T THINK THAT THE SURGEON WANTED TO REMOVE THE ROD COMPLETELY TO RECONTOUR THE ROD SO THAT IT WOULD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 11029637 ↗
• MalfunctionMay 1, 2018Break; Break

  ON (B)(6) 2018, THE SURGERY FOR PELVIC FRACTURE WAS PERFORMED BY USING THE EXPEDIUM SYSTEM. THE FIXED AREA WAS AT S2 - AI. DURING THE SURGERY, THE SURGEON NOTICED THAT A SET SCREW COULD NOT BE TIGHTENED INTO SAI POLYAXIAL SCREW (179704890) BECAUSE THE HEAD OF SAI POLYAXIAL SCREW WAS BROKEN. TO COMPLETE THE PROCEDURES, HE REPLACED THIS BROKEN SCREW WITH A NEW ONE. NO BROKEN PIECES WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS-THAN-30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7477036 ↗
• MalfunctionSep 18, 2017Torn Material; Torn Material

  ON (B)(6) 2017, SURGERY FOR VERTEBRAL OSTEOMYELITIS WAS PERFORMED USING THE EXPEDIUM VIPER SYSTEM. THE FIXED AREA WAS L2 ¿ S2. DURING THE SURGERY, THE SURGEON CONFIRMED THE FOLLOWING ISSUES. HE TRIED TO TIGHTEN THE SCREW (PART#:179704890, LOT#: TBFNL) WITH A DRIVER (PART# & LOT#: UNK). HE HEARD THE SCREW SPAN AT THE TIME OF TIGHTENING. HE DECIDED TO REPLACE IT WITH A NEW SCREW BECAUSE HE FELT THAT THE HEAD OF SCREW MIGHT BE A BIT STRIPPED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. AFTER THE SURGERY, THE SURGEON AND OUR SALES REP CONFIRMED THAT INNER PART OF THE SCREW HEAD WAS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6871761 ↗