VIPER 186731440Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 x 40mm · Class 2 · Implant
Data updated Oct 13, 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 10705034351421), received between Nov 19, 2021 and Nov 19, 2021 — classified as 2 injuries.
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
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2021Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WITH THE IMPLANTS IN QUESTION ON (B)(6) 2020. ON AN UNKNOWN DATE, ONE (1) POLYAXIAL SCREW BROKE AND ONE (1) POLYAXIAL SCREW MIGRATED. THE FIRST SCREW BROKE WHERE THE SCREW HEAD MEETS THE SCREW SHANK. THE SECOND SCREW PULLED OUT COMPLETELY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 40MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12848748 ↗InjuryNov 19, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WITH THE IMPLANTS IN QUESTION ON (B)(6) 2020. ON AN UNKNOWN DATE, ONE (1) POLYAXIAL SCREW BROKE AND ONE (1) POLYAXIAL SCREW MIGRATED. THE FIRST SCREW BROKE WHERE THE SCREW HEAD MEETS THE SCREW SHANK. THE SECOND SCREW PULLED OUT COMPLETELY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 40MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12848685 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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