ZEVO™ Anterior Cervical Plate System G7703515Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169398481), received between Jun 7, 2019 and Aug 6, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING SPINAL THERAPY FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT DURING THE SURGERY; THE SCREW LOCKING ISSUE OCCURRED. THE 90° SET SCREW WAS ROTATED, BUT IT TURNED ONCE BECAME LOOSE AND DID NOT STOP. THE SCREW AND PLATE WERE REMOVED AND REINSERTED. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724767 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION OF C3-C6 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OP, THE HEAD OF THE SCREW AT C4 BROKE DURING INSERTION. THE HEAD PART OF THE BROKEN SCREW WAS SUCCESSFULLY REMOVED FROM PATIENT'S BODY. ONLY THE SHAFT OF THE SCREW REMAINS IMPLANTED IN THE PATIENT BODY AS IT WAS VERY DIFFICULT TO REMOVE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677868 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL FIXATION OF C3-C6 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. INTRA-OP, THE HEAD OF THE SCREW AT C4 BROKE DURING INSERTION. THE HEAD PART OF THE BROKEN SCREW WAS SUCCESSFULLY REMOVED FROM PATIENT'S BODY. ONLY THE SHAFT OF THE SCREW REMAINS IMPLANTED IN THE PATIENT BODY AS IT WAS VERY DIFFICULT TO REMOVE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677848 ↗

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