ZEVO™ Anterior Cervical Plate System 7713518Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169329300), received between Mar 14, 2019 and Jan 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION THERAPY. IT WAS REPORTED THAT THE SCREW HEAD BROKE OFF FROM THE SHAFT UPON INSERTION. THE SHANK OF THE SCREW REMAINED IN THE VERTEBRAL BODY, UNABLE TO BACK OUT ONCE THE HEAD OF THE SCREW SHEARED OFF FROM THE SHANK DURING IMPLANTATION. IT WAS A NORMAL APPROACH TO PLACING SCREWS. AWL WAS USED TO CREATE PILOT HOLE FOR THE SCREW. THIS WAS THE FIFTH SCREW GOING IN OF EIGHT TOTAL. THE HEAD OF THE SCREW SHEARED OFF FROM THE SHANK WHEN ADVANCING THE SCREW THROUGH THE SCREW HOLE IN THE PLATE AND INTO THE VERTEBRAL BODY. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21236283 ↗
• MalfunctionMar 14, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: ANTERIOR CERVICAL DISC FUSION PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) LEVEL IMPLANTED: C4 IT WAS REPORTED THAT, INTRA-OP, SCREW CAUGHT PLATE, AND WHEN SCREW ADVANCED, IT SEEMED THE TORQUE CAUSED THE HEAD TO POP OFF THE SCREW. DUE TO THIS CAUSE SCREW HEAD DETACHED FROM THE SCREW. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. SCREW HEAD DETACHED FROM THE SCREW AND FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422042 ↗

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