VIPER 286715700Recalls & reported problems
Depuy Spine, LLC · VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 7mm 30-60mm Plus or Minus 0.24 Percent · Class 1
- 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 10705034214115), received between Jun 17, 2024 and Jun 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2024, IT WAS CONFIRMED THAT THERE WAS RESIDUAL BLOOD IN THE HOLLOW PORTION OF THE PRODUCTS IN QUESTION. THEY WERE CLEANED AND STERILIZED AGAIN AT THE HOSPITAL FOR USE ON THE FOLLOWING DAY, WEDNESDAY, (B)(6) 2024. THE FACILITY HAS A VERY HIGH LEVEL OF INFECTION AWARENESS. IT IS LIKELY TO AFFECT PRODUCT ADOPTION. THIS REPORT INVOLVES ONE (1) VIPER 2 SYSTEM TAP, CANNULATED AND SELF-DRILLING 5MM 30-60MM PLUS OR MINUS 0.24 PERCENT. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 19546659 ↗
Other TAP, BONE devices
- NA 311.43Synthes GmbH · TAP, BONE176 reports
- NA 311.01Synthes GmbH · TAP, BONE106 reports
- NA 311.431Synthes GmbH · TAP, BONE70 reports
- NA 03.424.124Synthes GmbH · TAP, BONE1 recall7 reports
- N/A 876-474Medtronic Sofamor Danek, Inc. · TAP, BONE1 recall0 reports
- NA 03.424.126Synthes GmbH · TAP, BONE1 recall0 reports
- A.L.P.S.® 8241-50-170Biomet Orthopedics, LLC · TAP, BONE1 recall0 reports
- NA 311.44Synthes GmbH · TAP, BONE41 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.