uNion Cervical Plate System UM102-02-34Recalls & reported problems
Ulrich Medical Usa, Inc. · Standard Cervical Plate, 2-Level, 34mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814386020145), received between Mar 27, 2018 and May 7, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- Unintended Movement2
- Use of Device Problem2
Patient problems
- Failure of Implant2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2018Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement
SURGEON REPORTED THAT POST-OP X-RAYS REVEALED A SCREW IS BACKING OUT FROM THE PLATE, INDICATING THAT THE PLATE'S BLOCKING MECHANISM MAY NOT HAVE FUNCTIONED AS INTENDED OR SCREW MAY HAVE BEEN OVER-ANGULATED. NO REVISION SURGERY HAS OCCURED.
Patient problems: Failure of Implant
MAUDE report 7490355 ↗MalfunctionMar 27, 2018Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement
SURGEON REPORTED THAT POST-OP X-RAYS REVEALED A SCREW IS BACKING OUT FROM THE PLATE, INDICATING THAT THE PLATE'S BLOCKING MECHANISM MAY NOT HAVE FUNCTIONED AS INTENDED. NO REVISION SURGERY HAS OCCURED.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 7373828 ↗
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 · TerminateduNion 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
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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