VIPER 186727775Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 x 7 x 75mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034282732), received between Jun 6, 2018 and Jun 6, 2018 — classified as 1 injury.
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 Consequences Or Impact To Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2018Break; Break
DOCTOR CALLED TO REPORT SCREW AT ILIAC ON RIGHT SIDE HAD BROKEN. IT WAS A 7.0 FENESTRATED SCREW. PLACED IN (B)(6) 2018. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION: HAD TO HAVE REVISION SURGERY AND HAVE SCREW REPLACED. ACTION TAKEN FOR PROCEDURE:SCREW REMOVED AND REPLACED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient; Not Applicable
MAUDE report 7573379 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page