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uNion Cervical Plate System UM150-40-14Recalls & reported problems

Ulrich Medical Usa, Inc. · Self Drilling Variable Screw, Magenta, 4.0x14mm · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814386020947), received between Jun 28, 2019 and Dec 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150666); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Device problems

  • Material Fragmentation2
  • Material Deformation1
  • Patient Device Interaction Problem1

Patient problems

  • Failure of Implant2
  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 20, 2021Material Deformation; Patient Device Interaction Problem; Material Deformation; Patient Device Interaction Problem

    SURGEON WAS NOT ABLE TO INSERT SELF-DRILLING SCREWS. REPORT 5 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13046070 ↗
  • MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation

    METAL SHAVING SHEERED OFF OF SCREWS DURING INSERTION. THE SHAVINGS WERE REMOVED AND THE SCREWS LEFT IN PLACE. REPORT 1/2.

    Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

    MAUDE report 8745558 ↗
  • MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation

    METAL SHAVING SHEERED OFF OF SCREWS DURING INSERTION. THE SHAVINGS WERE REMOVED AND THE SCREWS LEFT IN PLACE. REPORT 2/2.

    Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

    MAUDE report 8745557 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150666. One submission often covers many models, so check the product and lot details in each record.

  • Z-1878-2017 · Mar 7, 2017 · Terminated
    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide

Other Appliance, Fixation, Spinal Intervertebral Body devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page