VIPER 286705340Recalls & reported problems
Medos International Sàrl · VIPER SYSTEM NITINOL GUIDEWIRE, LONG AND DISPOSABLE 1.45mm · Class 1
All models of VIPER (121)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034507873), received between Sep 23, 2019 and Nov 11, 2025 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Entrapment of Device1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE ITEM BROKE OFF INSIDE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 23526527 ↗InjurySep 23, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, DURING SPINAL FUSION AND PEDICLE PREPARATION FOR LEFT S1 SCREW INSERTION. THE K-WIRE KINKED DURING SCREW INSERTION. REPORTEDLY, NITINOL K-WIRE WAS PLACED INTO THE PEDICLE PATHWAY. AN 8 X 45 VIPER CORTICAL FIX SCREW AND CANNULATED SCREW DRIVER WERE THEN PASSED OVER THE NITINOL K-WIRE. WHILE REMOVING THE K-WIRE THROUGH THE DISTAL PORTION OF THE SCREW DRIVER ASSEMBLY, THE SERRATED/ETCHED TIP (APPROXIMATELY 15MM) OF THE K-WIRE SNAPPED OFF INSITU, PAST THE ANTERIOR VORTEX OF THE S1 VERTEBRAL BODY. THE FRAGMENT WAS NOT RETRIEVABLE AND FLUOROSCOPY WAS TAKEN TO CONFIRM. SURGICAL DELAY OF 60 MINUTES. FRAGMENTS WAS GENERATED BUT UNRETRIEVABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND IT IS UNKNOWN IF THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: VIPER CORTICAL FIX SCREW , (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN); CANNULATED SCREWDRIVER, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 9106519 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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