VIPER 186727955Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 9 x 55mm · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034282916), received between Aug 1, 2019 and Aug 1, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2019Break; Break
DR. (B)(6) WAS IMPLANTING A 9X55MM VIPER FENESTRATED SCREW INTO THE LEFT SIDED L4 PEDICLE AND WHEN THE SCREW WAS ABOUT HALF-WAY IMPLANTED THE TIP OF THE SCREW DRIVER (2792-12-400) BROKE INSIDE THE HEAD OF THE SCREW. DR. (B)(6) COULD NOT REMOVE THE FRAGMENT, OR ADVANCE/REMOVE THE SCREW FROM THE PEDICLE. HE PROCEDED TO ATTEMPT TO REMOVE THE SCREW AND AFTER MANY ATTEMPTS AND 45 MINUTES LATER THE SCREW WAS REMOVED. HE IMPLANTED A 8X55MM SCREW IN ITS PLACE SUCCESSFULLY AND PROCEDED WITH THE REST OF THE SURGERY. THERE WAS NOT HARM TO THE PATENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: YES. IF YES, NUMBER OF MINUTES: 45 -60. ACTION TAKEN WHEN EVENT OCCURRED?: REMOVED THE IMPLANT AND PLACED A NEW ONE. WAS PROCEDURE SUCCESSFULLY COMPLETED?: YES. WERE FRAGMENTS GENERATED?: YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: NO. IF NO, EXPLAIN: IT TOOK 45-60 MINUTES TO REMOVE THE FRAGMENT FROM THE SCREWDRIVER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8850368 ↗
Other bone cement, posterior screw augmentation devices
- VIPER 186727645Medos International Sàrl · bone cement, posterior screw augmentation3 deaths27 reports
- VIPER 186727745Medos International Sàrl · bone cement, posterior screw augmentation23 reports
- EXPEDIUM VERSE 199723645Medos International Sàrl · bone cement, posterior screw augmentation21 reports
- EXPEDIUM VERSE 199723745Medos International Sàrl · bone cement, posterior screw augmentation13 reports
- VIPER 186727640Medos International Sàrl · bone cement, posterior screw augmentation2 deaths11 reports
- VIPER 186727850Medos International Sàrl · bone cement, posterior screw augmentation9 reports
- EXPEDIUM VERSE 199723435Medos International Sàrl · bone cement, posterior screw augmentation6 reports
- EXPEDIUM VERSE 199723535Medos International Sàrl · bone cement, posterior screw augmentation4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.