VIPER 186727765Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034282718), received between Mar 13, 2019 and Mar 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT - THE HEAD OF THE SCREW WAS DISASSEMBLED WHEN THE ALIGNMENT GUIDE WAS INTRODUCED WITH A HAMMER FOR INSERTING THE LOCK CAP IN A VIPER CORTICAL FIX FENESTRATED SCREW. THE SQUARE THREAD OF 2 VERSE CORRECTION KEYS WERE BROKEN WHEN THEY WERE INSERTED IN THE HEAD OF THE SCREW. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, ACTION TAKEN WHEN EVENT OCCURRED? --> TO CHANGE THE SCREW AND THE CORRECTION KEYS, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416828 ↗