VIPER PRIME 186750440Recalls & reported problems
Medos International Sàrl · VIPER PRIME CFX FEN X-TAB POLYAXIAL SCREW 5.5 5 x 40mm · Class 2 · Implant
All models of VIPER PRIME (60)
Data updated Oct 18, 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 10705034509181), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2024 IT WAS NOTICED THE VIPER PRIME SCREWS WERE DAMAGED. WHEN THE SCREW WAS REMOVED FROM THE STERILE FIELD TO INSPECT IT; THE SCREW THEN BECAME DISASSEMBLED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR A VIPER PRIME SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632948 ↗
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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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