ZEVO™ Anterior Cervical Plate System 3001027Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169329881), received between Jan 11, 2021 and Jan 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141632); 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.

• InjuryJan 11, 2021Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN ACDF PROCEDURE. LEVELS IMPLANTED: C4-5. IT WAS REPORTED POST- OPERATIVELY, THE LOCKING MECHANISM BENT AND ALLOWED THE SCREW TO BACK OUT. IMPLANT DATE IS UNKNOWN. . A REVISION SURGERY WAS COMPLETED ON (B)(6)2020, TO REMOVE THE BENT PLATE AND OLD SCREWS. PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146149 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141632. One submission often covers many models, so check the product and lot details in each record.

• Z-1750-2018 · Mar 23, 2018 · Terminated
  Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body