ZEVO™ Anterior Cervical Plate System G7783513Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169398627), received between Aug 22, 2019 and Apr 11, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 4 most recent of 4 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 19089196 ↗
• MalfunctionAug 21, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL FUSION FOR CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT ON (B)(6), THE ZV WAS INITIALLY USED. LESS THAN 3 WEEKS AFTER THE SURGERY, DISLODGEMENT (MIGRATION) OF THE BONE GRAFT WAS OBSERVED. COMPARATIVE IMAGES OF POSTOPERATIVE AND MOST RECENT X-RAY IMAGING WERE OBTAINED. THE GRAFTED BONE COLLAPSED 20¿30° POSTERIORLY. AS A RESULT, THE L4 LOWERENDPLATE - THE L6 UPPER ENDPLATE WILL DECREASE BY 4-5 MM, AND THE C6 SCREW ANGLE WILL BE -10° (IT WAS BELIEVED THAT THE VARIABLE MECHANISM WAS ACTIVATED).  THE PATIENT RECEIVED AN ILIAC BONE GRAFT FOR THE C5 CORPECTOMY AND PLATE FIXATION FOR THE C4-6. THE GENERAL FLOW OF THE PROCEDURE IS AS FOLLOWS: DEPLOYMENT WITH A PIN DISTRACTOR, ILIAC BONE GRAFTING, AND FIXATION WITH A PLATE. SINCE IT WASFIX-GROUP, THE GRAFTED BONE WAS MORE FIRM THAN LOOSE; IT WAS SLIGHTLY TAPPED AND INSERTED DURING THE ILIAC GRAFT. WHEN DISTRACTION WAS LOOSENED AND CHECKED, THERE WAS NO FEELING OF MOVEMENT, AND IT WAS STEADY. THE VERTEBRAL ENDPLATE WAS ALSO NOT DISRUPTED. NO SINKING WAS OBSERVED, AND IT SEEMED LIKE IT HAD DISLODGED BE

  Patient problems: Pain

  MAUDE report 17583151 ↗
• InjuryAug 22, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FIXATION AT C4-7 DUE TO LUMBAR SPINAL CANAL STENOSIS. POST-OP, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREWS MIGRATION AT C7. IN THE REVISION SURGERY, THE SURGEON REMOVED THE IMPLANTS, CUT THE BONE SPICULE, REPLACED ALL OF THE SCREWS WITH LONGER SCREWS. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8919709 ↗
• InjuryAug 22, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR FIXATION AT C4-7 DUE TO LUMBAR SPINAL CANAL STENOSIS. POST-OP, THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREWS MIGRATION AT C7. IN THE REVISION SURGERY, THE SURGEON REMOVED THE IMPLANTS, CUT THE BONE SPICULE, REPLACED ALL OF THE SCREWS WITH LONGER SCREWS. THERE WAS A DELAY OF MORE THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8919691 ↗

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