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AMDT Mini-Rail 1Recalls & reported problems

Arrowhead De LLC · Rail, 150mm · Class 2 · Implant

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 00855967006370), received between May 24, 2019 and May 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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

  • Difficult or Delayed Positioning1

Patient problems

  • Congenital Defect/Deformity1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 24, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

    CLAMP WOULD NOT ADVANCE ON THE RAIL.

    Patient problems: Congenital Defect/Deformity

    MAUDE report 8640240 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.