ZEVO™ Anterior Cervical Plate System G7713515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169327676), received between Jan 12, 2022 and Jan 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 12, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A C6/7 ANTERIOR CERVICAL DECOMPRESSION AND FUSION PROCEDURE. IT WAS REPORTED THAT A SCREW HAS BACKED OUT AND BEEN LOST WITHIN THE PATIENT AND ANOTHER SCREW WAS LOOSE ON THE BOTTOM LEVEL, BUT IT IS STILL IN THE BONE. NO PATIENT INJURY/COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13234275 ↗

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