VIPER PRIME 3010-19-010Recalls & reported problems
Medos International Sàrl · NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER · Class 2
All models of VIPER PRIME (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034561684), received between Feb 18, 2022 and Feb 22, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING A LUMBAR FUSION SURGERY, THE 8MM TIP/TAP WAS INSERTED IN BONE USING THE DSS POWER HAND PIECE. AS THE PEDICLE WAS BEING TAPPED, THE ARRAY BECAME LOCKED TO THE TAP. ONCE THIS HAPPENED, THE ARRAY WOULD ROTATE 360 DEGREES WITH THE TAP. THE LOCK ARRAY ALSO LOCKED ONTO THE VIPER PRIME DRIVER. BOTH INSTRUMENTS WERE USED ON POWER. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. NO VISIBLE FRAGMENTS WERE NOTICED. PATIENT STATUS IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13577501 ↗MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, DURING LUMBAR FUSION SURGERY, THE ARRAY LOCKED ONTO THE DRIVER WHILE THE SCREW WAS BEING INSERTED INTO THE BONE. THE SCREW WAS BEING INSERTED WITH THE POWER HAND PIECE. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) NAVIGATION ENABLED INSTRUMENTS VIPER PRIME DRIVER THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559392 ↗
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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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