VIPER 286735600Recalls & reported problems
Depuy Spine, LLC · VIPER 2 SYSTEM COMPRESSION SLEEVE ASSEMBLY · Class 1
All models of VIPER (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 10705034214658), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
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.
MalfunctionApr 19, 2023Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE COMPRESSION SLEEVE AND FULCRUM ARE NOT SLIDING NICELY AND IS GETTING STUCK. THERE WERE NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) COMPRESSION SLEEVE ASSEMBLY THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16771242 ↗
Other CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY devices
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- ENDOPATH TT012Ethicon Endo-Surgery, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY47 reports
- NA 03.168.013Synthes GmbH · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY37 reports
- NA 214120Medos International Sàrl · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Monoject 8881540111Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY19 reports
- MOSS 279712500Depuy Spine, LLC · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY12 reports
- Monoject 8881540133Cardinal Health, Inc. · CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY10 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 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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