VIPER 286735050Recalls & reported problems
Depuy Spine, LLC · VIPER 2 SYSTEM ROD GAUGE 30-140mm Plus or Minus 1.67 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 10705034214498), received between May 23, 2018 and May 23, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2018Break; Break
WHEN MEASURING THE ROD ON A POSTERIOR LUMBAR FUSION L4-S1, THE CALIPER APPEARED TO PROTRUDE THROUGH THE LEFT SIDED L4 SCREW EXTENSION AND WOULD NOT COME OUT. HE WAS FORCED TO CUT THE CALIPER WITH A BOLT CUTTER. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7537844 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.