ZEVO™ Anterior Cervical Plate System G7783515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169398603), received between Nov 28, 2018 and Apr 11, 2024 — classified as 2 injuries.

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.

• InjuryApr 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. PRE-OP DIAGNOSIS WAS CERVICAL KYPHOSIS. IT WAS REPORTED THAT, PATIENT HAD DISCOMFORT DUE TO PLATE DISLODGEMENT. AFTER C5/6 DECOMPRESSION, 11MM CAGE WAS PLACED AND MIGRATION OF C5/6 CAGE ALREADY OCCURRED AFTER COMBINED POSTERIOR FIXATION. AFTER 1 WEEK POSTOPERATIVELY, FURTHER MIGRATION OF THE CAGE AND HEAD SIDE DISLODGEMENT OF THE C4-7 ZEVO PLATE OCCURRED. TOTAL REMOVAL OF PLATE AND REMOVAL OF  11MM CAGE AT C5/6, AUTOLOGOUS ILIAC BONE TRANSPLANTATION BETWEEN C5/6 VERTEBRAE WAS RETRIEVED DURING REVISION SURGERY.  THE 13MM SCREW AT C4 AND 15MM SCREW AT C7 WAS FOUND LOOSE AND THEY WERE EXPLANTED. PROCEDURE OR TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS C4-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION. THERE WERE NO PARTICULAR PROBLEMS WITH 5MM CAGE.  NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19089456 ↗
• InjuryNov 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOTIC RADICULOPATHY AND UNDERWENT ANTERIOR FUSION AT C4/5/6.POST-OP, SCREW BREAKAGE AT C6 WAS REPORTED. DYSRAPHISM AND RECURRENCE OF SYMPTOMS WERE REPORTED AS THE RESULT OF THE EVENT. POSTERIOR CERVICAL DECOMPRESSION AND FUSION WAS PERFORMED ADDITIONALLY ON (B)(6) 2018.

  Patient problems: Failure of Implant; Neurological Deficit/Dysfunction

  MAUDE report 8113582 ↗

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