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ALIF 273505103Recalls & reported problems

Depuy Spine, LLC · UNIVERSAL ALIF INSTRUMENT SET DISC RONGEUR, STRAIGHT 3mm · 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 10705034190136), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionJan 5, 2021Material Deformation; Material Deformation

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING THE DISC PREPARATION FOR AN L5/S1 L4/5 ALIF (ANTERIOR LUMBAR INTERBODY FUSION), THE SURGEON WAS USING THE ALIF DISC RONGEUR STRAIGHT 3MM ON TOUGH DISC MATERIAL AND BENT THE TIPS OF THE INSTRUMENT. THE WERE UNABLE TO CLOSE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) ALIF DISC RONGEUR STRAIGHT 3MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11117284 ↗

Other RONGEUR devices

All RONGEUR devices →

Sources and updates

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