ALIF 273505105Recalls & reported problems
Depuy Spine, LLC · UNIVERSAL ALIF INSTRUMENT SET DISC RONGEUR, STRAIGHT 5mm · Class 1
Data updated Oct 16, 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 10705034190143), received between Aug 24, 2023 and Aug 24, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionAug 24, 2023Break; Break
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THERE IS A CRACK IN THE METAL STUD THAT IS ON THE INSIDE OF ONE OF THE HANDLES. THIS REPORT IS FOR ONE (1) ALIF DISC RONGEUR STRAIGHT 5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17618241 ↗
Other RONGEUR devices
- SPOTLIGHT 292904201Depuy Spine, LLC · RONGEUR6 reports
- Symmetry RapidClean® 58-3200J-BDAspen Surgical Products, Inc. · Rongeur5 reports
- SPOTLIGHT 292904202Medos International Sàrl · RONGEUR5 reports
- NA 03.605.001Synthes GmbH · RONGEUR4 reports
- Medicon 57.28.33Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR3 reports
- AESCULAP FF805RAesculap AG · RONGEUR3 reports
- Symmetry Rapidclean® 58-3200-BDAspen Surgical Products, Inc. · Rongeur3 reports
- Integra® Jarit® 280405Integra Lifesciences Production Corporation · RONGEUR3 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 13, 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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