ZEVO™ Anterior Cervical Plate System 3001015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169329829), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN THE MONTH OF (B)(6) 2019, POST-OP, THE LOCKING MECHANISM WAS NOTICED TO BE NOT COVERING ALL THE SCREWS; AND ONE OF THE 13MM SCREWS HAD BACKED OUT. UPON EXPLANTATION, IT WAS SEEN THAT THE LOCKING MECHANISM DID NOT SIT FLUSH AGAINST THE PLATE. THERE WAS A SINGLE LOCKING MECHANISM ON THE 15MM PLATE. THE PLATE WAS COMPLETELY EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9581922 ↗

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