ZEVO™ Anterior Cervical Plate System G3002037Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169327504), received between Jan 3, 2025 and Jan 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• MalfunctionJan 3, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL FUSION FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT ON JULY 7, THE ZV WASINITIALLY USED. LESS THAN 3 WEEKS AFTER THE SURGERY, DISLODGEMENT (MIGRATION) OF THE BONE GRAFT WAS OBSERVED. COMPARATIVE IMAGES OF POSTOPERATIVE AND MOST RECENT X-RAY IMAGING WERE OBTAINED. THE GRAFTED BONE COLLAPSED 20¿30° POSTERIORLY. AS A RESULT, THE L4 LOWERENDPLATE - THE L6 UPPER ENDPLATE WILL DECREASE BY 4-5 MM, AND THE C6 SCREW ANGLE WILL BE -10° (IT WAS BELIEVED THAT THE VARIABLE MECHANISM WAS ACTIVATED). THE PATIENT RECEIVED AN ILIAC BONE GRAFT FOR THE C5 CORPECTOMY AND PLATE FIXATION FOR THE C4-6. THE GENERAL FLOW OF THE PROCEDURE IS AS FOLLOWS: DEPLOYMENT WITH A PIN DISTRACTOR, ILIAC BONE GRAFTING, AND FIXATION WITH A PLATE. SINCE IT WASFIX-GROUP, THE GRAFTED BONE WAS MORE FIRM THAN LOOSE; IT WAS SLIGHTLY TAPPED AND INSERTED DURING THE ILIAC GRAFT. WHEN DISTRACTION WAS LOOSENED AND CHECKED, THERE WAS NO FEELING OF MOVEMENT, AND IT WAS STEADY. THE VERTEBRAL ENDPLATE WAS ALSO NOT DISRUPTED. NO SINKING WAS OBSERVED, AND IT SEEMED LIKE IT HAD DISLODGED BEHI

  Patient problems: Pain

  MAUDE report 21065363 ↗

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