uNion Cervical Plate System UM144-40-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814386020848), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionJun 28, 2019Difficult to Remove; Difficult to Remove

  SURGEON TRIED TO REMOVE SCREW DURING INITIAL SURGERY AND WAS NOT ABLE TO BECAUSE IT WAS STRIPPED. THE SCREW WAS LEFT IN PLACE.

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

  MAUDE report 8745560 ↗

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