VIPER 186719765Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM CLOSED POLYAXIAL SCREW 5.5 7 x 65mm · Class 2 · Implant
All models of VIPER (121)
Data updated Oct 18, 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 10705034280172), received between Nov 29, 2018 and Feb 7, 2019 — classified as 2 injuries.
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
Device problems
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2019Break; Break
IT WAS REPORTED FOLLOWING ANALYSIS PERFORMED AFTER THE INITIAL IMPLANTATION WHICH WAS PERFORMED ON (B)(6) 2018, IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN. NO DATE OR CONTRIBUTING FACTOR OF THE INCIDENT WERE PROVIDED. SURGICAL INTERVENTION WAS PERFORMED WITH THE PATIENT FOR REVISION OF THE ASSEMBLY.
Patient problems: No Code Available
MAUDE report 8316692 ↗InjuryNov 29, 2018Break; Break
IT WAS REPORTED FOLLOWING ANALYSIS PERFORMED AFTER THE INITIAL IMPLANTATION WHICH WAS PERFORMED ON (B)(6) 2018, IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN. NO DATE OR CONTRIBUTING FACTOR OF THE INCIDENT WERE PROVIDED. SURGICAL "INTEVENTION" WAS PERFORMED WITH THE PATIENT FOR REVISION OF THE ASSEMBLY.
Patient problems: No Code Available
MAUDE report 8115636 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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