uNion Cervical Plate System UM102-01-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814386020046), received between Jan 16, 2020 and Jan 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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

Recent adverse event reports

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

• MalfunctionJan 16, 2020Material Separation; Migration; Material Separation; Migration

  X-RAYS APPROXIMATELY 8 MONTHS POST OP REVEALED PLATE'S LOCKING MECHANISM HAD DETACHED FROM THE PLATE AND THAT THE LOCKING MECHANISM HAD MIGRATED IN THE PATIENT. NO REVISION IS SCHEDULED, PATIENT CONDITION IS BEING MONITORED.

  Patient problems: Discomfort; Failure of Implant; Foreign Body In Patient

  MAUDE report 9598495 ↗

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