ZEVO™ Anterior Cervical Plate System 7723513Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169328938), received between Nov 11, 2021 and May 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST C3/6 ANTERIOR CERVICAL ANTERIOR DISCECTOMY AND FUSION PROCEDURE IN A PATIENT DIAGNOSED WITH STENOSIS/MYELOPATHY. IT WAS REPORTED THAT THE INFERIOR SCREWS AT C6 LEVEL BROKE BILATERALLY AND LOCKING CAP FOR PLATE AT INFERIOR LEVEL BROKE. PATIENT HAD PSEUDO ARTHROSIS AT C5/6 LEVEL. THERE IS NO PLAN TO EXPLANT THE PRODUCTS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14266116 ↗
• MalfunctionNov 11, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A COMPETENT AUTHORITY (DECLARATION NUMBER (B)(4)) & HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH THE SCREWS & PLATES WITH ANTERIOR CERVICAL FIXATION THERAPY. IT WAS REPORTED THAT THE SURGEON SCREWED AND UNSCREWED THE SCREWS SEVERAL TIMES THROUGH THE PLATE AND CHANGED SIZES. AS A RESULT, A STEEL WOOL APPEARED. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791937 ↗

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