VIPER 186760135Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM X-TAB CORTICAL FIX POLYAXIAL SCREW 5.5 6.0mm x 35mm · Class 2 · Implant
All models of VIPER (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034465449), received between Aug 16, 2017 and Aug 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation1
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 16, 2017Material Deformation; Material Deformation
ON (B)(6) 2017, SURGERY WAS PERFORMED USING THE XTAB/CFS SYSTEM. THE FIXED ARE WAS L2-SAI. AT THE TIME OF INSERTING THE SCREW USING THE CBT TRAJECTORY METHOD, THE SURGEON FAILED TO SNAP THE TAB WELL, THUS A BURR WAS LEFT ON THE TAB AND THE THREAD DEFORMED. FINALLY, HE COULD NOT ATTACH THE SCREW ONTO THE DRIVER. HE DEALT WITH THIS EVENT BY REPLACING THE SCREW IN QUESTION WITH A NEW ONE. THERE ARE NO BROKEN PARTS FOUND LEFT IN THE BODY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 5-MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE HOSPITAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6798386 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page