VIPER 186727945Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 9 x 45mm · Class 2 · Implant
All models of VIPER (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034282893), received between Nov 16, 2017 and Nov 16, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection2
Patient problems
- Failure of Implant2
- Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 16, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
REVISION SURGERY. TWO LOOSE EXPEDIUM 7MM POLY SCREW IN L5 WERE REPLACED THRUE A VIPER CFX 9X45MM SCREW. FOR BOTH SCREWS THE 9MM VIPER TAB WAS USED THE FULL LENGTH OF THE SCREW. BUT AFTERWARDS BOTH SCREWS GOT STUCK IN THE PEDICLE WHEN THE 4-FOLD THREAD OF THE SCREWS WAS TURNED INTO THE BONE. NO WAY FOR SCREWING OR UNSCREWING. THE SURGEON HAD TO REMOVE PEDICLE-BONE UNTIL THE 4-FOLD THREAD WAS FREE UND THE SCREWS COULD BE UNSCREWED. BOTH 9X45 CFX SCREWS WERE NOT USABLE AFTER REMOVAL. AFTERWARDS 8MM CFX SCREWS WERE USED.
Patient problems: Failure of Implant; Injury
MAUDE report 7036493 ↗InjuryNov 16, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
REVISION SURGERY. TWO LOOSE EXPEDIUM 7MM POLY SCREW IN L5 WERE REPLACED THRUE A VIPER CFX 9X45MM SCREW. FOR BOTH SCREWS THE 9MM VIPER TAB WAS USED THE FULL LENGTH OF THE SCREW. BUT AFTERWARDS BOTH SCREWS GOT STUCK IN THE PEDICLE WHEN THE 4-FOLD THREAD OF THE SCREWS WAS TURNED INTO THE BONE. NO WAY FOR SCREWING OR UNSCREWING. THE SURGEON HAD TO REMOVE PEDICLE-BONE UNTIL THE 4-FOLD THREAD WAS FREE UND THE SCREWS COULD BE UNSCREWED. BOTH 9X45 CFX SCREWS WERE NOT USABLE AFTER REMOVAL. AFTERWARDS 8MM CFX SCREWS WERE USED.
Patient problems: Failure of Implant; Injury
MAUDE report 7036455 ↗
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.
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