VIPER 186727855Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034282800), received between Mar 12, 2018 and Sep 6, 2018 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT IT WAS DIFFICULT TO SCREW IN THE CFX SCREW INTO THE PEDICLE, IN FOLLOW THE SCREW HEAD HAS LOOSEN FROM SHAFT. NO PATIENT HARM, SURGERY DELAY OF 15 MIN.

  Patient problems: Not Applicable

  MAUDE report 7850142 ↗
• InjuryJul 13, 2018Break; Break

  DR. (B)(6) WAS DOING A REVISION SURGERY IN (B)(6). THE PATIENT HAD VIPER SCREWS SIZE 7X50 AND 7X55 IMPLANTED ON L3 TO L5 LINKED TOGETHER WITH A TITANIUM ROD. THERE WAS A TLIF CAGE IN BETWEEN L4-L5 WITH PSEUDOARTHROSIS. THE PATIENT ALSO HAD SCREWS FROM AN UNKNOWN SYSTEM ON S1 WHICH WERE NOT LINKED WITH THE REST OF THE CONSTRUCT AND COULDN¿T BE REMOVED IN PREVIOUS SURGERIES. INDEED, THIS APPARENTLY WAS THE 5TH OR 6TH TIME THAT THIS PATIENT WAS UNDERGOING A SPINE SURGERY IN THE LUMBAR AREA. UPON REMOVING THE VIPER SCREW ON THE LEFT PEDICLE OF L3, THE SCREWDRIVER 279734000 TIP BROKE IN THE SCREW HEAD BEFORE THE SCREW COULD BE FULLY UNTHREADED. THE TIP OF THE SCREWDRIVER COULD BE REMOVED FROM THE SCREW HEAD. A SMALL ROD HAS THEN BEEN INSERTED IN THE SCREW HEAD AND BLOCKED WITH AN INNIE TO LOCK THE POLYAXIALITY OF THE SCREW. THE SCREW COULD THEN BE REMOVED. TO REPLACE THE REMOVED 7MM SCREW, THE SURGEON DECIDED TO IMPLANT A CFX 8X55 SCREW (186727855). NO TAPING WAS DONE PRIOR TO INSERTING THE SCREW. WHILE INSERTING THE SCREW ON THE LEFT PEDICLE OF L3 WITH ANOTHER SCREWDRIVER 279734000, THE SCREWDRIVER TIP OF THIS NEW SCREWDRIVER BROKE IN THE SCREW HEAD. THE SURGEON TRIED TO REMOVE THE SCR

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7685349 ↗
• MalfunctionApr 30, 2018Disassembly; Disassembly

  SCREW HEAD DECLAMPED (NO BREAKAGE) INTRAOPERATIVELY FROM SCREW SHAFT DURING SCREW INSERTION (EXPEDIUM CFX 186727855). SCREW INSERTION WAS PERFORMED USING THE MIS ALIGNMENT DEVICE (2797-26-400) AND AN SRT ADAPTER AND T HANDLE. SCREW HEAD DECLAMPED HALF WAY IN THE PEDICLE. SCREW SHAFT WAS THEN REMOVED AND A NEW SCREW WAS IMPLANTED USING THE REGULAR SCREW DRIVER. PATIENT CONSEQUENCE? UNKNOWN. ACTION TAKEN FOR PROCEDURE:SCREW WAS REMOVED AND A NEW SCREW HAD TO BE IMPLANTED. COULD HAVE WEAKENED THE PEDICLE. NEW SCREW WAS AUGMENTED USING CONFIDENCE. WHETHER THE SCREW WILL LOOSEN MUST BE MONITORED. 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 7474107 ↗
• MalfunctionMar 12, 2018Break; Break

  IT WAS DIFFICULT TO SCREW IN THE CFX SCREW, AT LEAST THE 3-D SCREW HEAD HAS LOOSEN FROM SHAFT. SURGERY DELAY OF 15 MIN, NO PATIENT HARM.

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

  MAUDE report 7331924 ↗