VIPER 186727980Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034282961), received between Jul 20, 2018 and Dec 20, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT OPERATED WITH EXPEDIUM 5.5 CA 1 YEAR AGO. THE ROD HAD SLIPPED OUT OF THE PATIENT, LEAVING THE CONSTRUCTION NOT SATISFYING. PATIENT WAS FINE FOR THE FIRST MONTHS AFTER FIRST SURGERY. THEN AFTER A WHILE HE GOT MORE BACK PROBLEM AGAIN. REOPERATION SHOWS THAT SOME OF THE SETS SCREW ON THE DISTAL PART OF THE CONSTRUCTION WAS NOT THAT HARD TO OPEN(SEEMED LIKE THEY WHERE NOT AS TIGHT AS THEY SHOULD BE, FINAL TIGHTENING WAS DONE BY DOCTORS DURING SURGERY FIRST TIME). ON THE RIGHT SIDE THE ROD WAS JUST INSIDE THE DISTAL SCREW, ALMOST ON IT-S WAY OUT AS WELL. CONSTRUCTION WAS FROM L2 TO S1 WITH ILIUM SCREWS BILAT. THE ONE ILIUM SCREW THE WHOLE TULIP JUST HAD LOOSEN FROM IT SCREW AND WAS HANGING ON THE ROD, WITHOUT BEING ON THE SCREW ITSELF. DURING SURGERY (TODAY) THEY WHERE TAPPING WITH A 10 MM TAP BEFORE PUTTING IN 10X80 VIPER CORTICAL FIX SCREW IN THE OLD ILIUM FIXATION (THEY TOOK OUT 9X80) THE TWO POLYAXIAL SCREW DRIVER BROKE , AND THE VIPER SCREWDRIVER. THE VIPER PART GOT STUCK IN THE SCREW WHILE IT WAS HALF WAY IN THE BONE, THEY TRIED TO TAKE I OUT, BUT WITH NO LUCK, LEAVING IT TO NO OTHER CHOSE THAN SAW OF THE PART THAT WAS OUTSIDE THE BONE, LEAVING THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8185914 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED THAT "THE PATIENT OPERATED WITH EXPEDIUM 5.5 CA 1 YEAR AGO. THE ROD HAD SLIPT OUT OF THE PATIENT, LEAVING THE CONSTRUCTION NOT SATISFYING. PATIENT WAS FINE FOR THE FIRST MONTHS AFTER FIRST SURGERY. THEN AFTER A WHILE HE GOT MORE BACK PROBLEM AGAIN. REOPERATION SHOWS THAT SOME OF THE SETS SCREW ON THE DISTAL PART OF THE CONSTRUCTION WAS NOT THAT HARD TO OPEN(SEEMED LIKE THEY WHERE NOT AS TIGHT AS THEY SHOULD BE, FINAL TIGHTENING WAS DONE BY DOCTORS DURING SURGERY FIRST TIME). ON THE RIGHT SIDE THE ROD WAS JUST INSIDE THE DISTAL SCREW, ALMOST ON IT-S WAY OUT AS WELL. CONSTRUCTION WAS FROM L2 TO S1 WITH ILIUM SCREWS BILAT. THE ONE ILIUM SCREW THE WHOLE TULIP JUST HAD LOOSEN FROM IT SCREW AND WAS HANGING ON THE ROD, WITHOUT BEING ON THE SCREW ITSELF. DURING SURGERY (TODAY) THEY WHERE TAPPING WITH A 10 MM TAP BEFORE PUTTING IN 10X80 VIPER CORTICAL FIX SCREW IN THE OLD ILIUM FIXATION (THEY TOOK OUT 9X80) THE TWO POLYAXIAL SCREW DRIVER BROKE , AND THE VIPER SCREWDRIVER. THE VIPER PART GOT STUCK IN THE SCREW WHILE IT WAS HALF WAY IN THE BONE, THEY TRIED TO TAKE I OUT, BUT WITH NO LUCK, LEAVING IT TO NO OTHER CHOSE THAN SAW OF THE PART THAT WAS OUTSIDE THE BONE, LEAVING THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8185826 ↗
• MalfunctionJul 20, 2018Break; Break

  REVISION SURGERY FOR SAME PATIENT AS COMPLAINT (B)(4). ONE ILIAC SCREW CFX 9X80 BROKE POST OP, APROX 2-3 MONTHS AFTER SURGERY. WITH HELP OF A SCREWDRIVER, THE SURGEON COULD REMOVE THE HEAD AND THE PROXIMAL PORTION OF THE SCREW SHANK. AS TO THE DISTAL PORTION OF THE SCREW SHANK, SURGEON TRIED TO REMOVE IT WITH A REAMER BUT DIDN¿T HAVE ONE LARGE ENOUGH TO REMOVE A 9MM DIAMETER SCREW, SO THEY LEFT IT IN. THEY THEN DECIDED TO REMOVE THE SECOND 9MM ILIAC SCREW. THEY COULDN¿T INSERT THE SCREWDRIVER IN THE SCREW HEAD BECAUSE THE TIP OF THE BROKEN SCREWDRIVER FROM THE PREVIOUS SURGERY WAS STILL LEFT IN THE HEAD (PREVIOUS COMPLAINT REPORT). THEY DECIDED TO INSERT A SMALL ROD IN THE SCREW HEAD AND TO LOCK IT WITH A SET SCREW TO MONOAXIALIZE THE ILIAC SCREW. HOWEVER, UPON UNSCREWING, THE SCREW HEAD BROKE. THEY REMOVED IT FROM THE SHANK AND TRIED UNSCREWING THE SCREW SHANK WITH VARIOUS INSTRUMENTS BUT FAILED TO DO SO. THE SURGEON FINALLY DECIDED TO LEAVE THE SECOND BROKEN SCREW IN AS WELL. TO BE ABLE TO FINALIZE THE CONSTRUCT THE SURGEON HAS USED SAI SCREWS. THANKS TO THE ALTERNATIVE TRAJECTORY SAI SCREWS ALLOW, THEY COULD IMPLANT THEM WITHOUT CONFLICTING WITH THE ILIAC SHANKS FROM THE PREVIOU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707804 ↗
• InjuryJul 20, 2018Break; Break

  REVISION SURGERY FOR SAME PATIENT AS (B)(4). ONE ILIAC SCREW CFX 9X80 BROKE POST OP, APROX 2-3 MONTHS AFTER SURGERY. WITH HELP OF A SCREWDRIVER, THE SURGEON COULD REMOVE THE HEAD AND THE PROXIMAL PORTION OF THE SCREW SHANK. AS TO THE DISTAL PORTION OF THE SCREW SHANK, SURGEON TRIED TO REMOVE IT WITH A REAMER BUT DIDN¿T HAVE ONE LARGE ENOUGH TO REMOVE A 9 MM DIAMETER SCREW, SO THEY LEFT IT IN. THEY THEN DECIDED TO REMOVE THE SECOND 9 MM ILIAC SCREW. THEY COULDN¿T INSERT THE SCREWDRIVER IN THE SCREW HEAD BECAUSE THE TIP OF THE BROKEN SCREWDRIVER FROM THE PREVIOUS SURGERY WAS STILL LEFT IN THE HEAD (PREVIOUS COMPLAINT REPORT). THEY DECIDED TO INSERT A SMALL ROD IN THE SCREW HEAD AND TO LOCK IT WITH A SET SCREW TO MONOAXIALIZE THE ILIAC SCREW. HOWEVER, UPON UNSCREWING, THE SCREW HEAD BROKE. THEY REMOVED IT FROM THE SHANK AND TRIED UNSCREWING THE SCREW SHANK WITH VARIOUS INSTRUMENTS BUT FAILED TO DO SO. THE SURGEON FINALLY DECIDED TO LEAVE THE SECOND BROKEN SCREW IN AS WELL. TO BE ABLE TO FINALIZE THE CONSTRUCT THE SURGEON HAS USED SAI SCREWS. THANKS TO THE ALTERNATIVE TRAJECTORY SAI SCREWS ALLOW, THEY COULD IMPLANT THEM WITHOUT CONFLICTING WITH THE ILIAC SHANKS FROM THE PREVIOUS SURGER

  Patient problems: Pain

  MAUDE report 7707626 ↗