ZEVO™ Anterior Cervical Plate System G3002041Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169327641), received between Oct 23, 2019 and Apr 2, 2024 — classified as 2 injuries.

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

• InjuryApr 2, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A PLATE AND SCREW IN AN ANTERIOR CERVICAL SPINE FIXATION AT C4/6 FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT THE C6 RIGHT SCREW BACKOUT WAS OBSERVED, SO THE SCREW WAS REMOVED. BONE FUSION WAS OBTAINED. WHEN THE PLATE WAS CHECKED DURING REMOVAL AND DEPLOYMENT, THE LOCKING PLATE WAS NOT LOCKED. IT IS CURRENTLY UNKNOWN WHETHER THE LOCKING OF THE PLATE WAS FORGOTTEN DURING THE INITIAL OPERATION OR IT UNLOCKED POSTOPERATIVELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. REMOVAL TOOK PLACE DUE TO SCREW BACK OUT. THE BACKED OUT SCREW HAD MORE DAMAGES COMPARED TO THE OTHER 5. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017655 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT :ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OPERATIVELY ,THERE WAS A POSSIBILITY OF SPINAL CORD INJURY BEYOND THE POSTERIOR WALL OF THE VERTEBRAL BODY AND RUPTURE OF POSTERIOR WALL OF PATIENT'S VERTEBRAL BODY.

  Patient problems: Rupture; Spinal Cord Injury

  MAUDE report 9224098 ↗

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