ZEVO™ Anterior Cervical Plate System G7724015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169327870), received between Aug 21, 2020 and Aug 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryAug 21, 2020Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE. PRE-OP DIAGNOSIS: CROSS-LINK WAS CONFIRMED IN THE JUDGMENT OF SOLID FUSION, IT WAS DECIDED TO REMOVE THE IMPLANT. PATIENT ACHIEVED SOLID FUSION. LEVELS IMPLANTED: C4-7. IT WAS REPORTED THAT THE EVENT OCCURRED BECAUSE THE PERSON IN CHARGE OF THE FACILITY(B)(4) DID NOT CHECK THE OPERATION HISTORY THAT IMPLANT REMAINED. THE REMOVAL EQUIPMENT WAS SHIPPED FROM (B)(4) LOANER, AND STERILIZED AT HIGH SPEED AND REMOVAL WAS PERFORMED. SURGERY WAS DELAYED MORE THAN 60 MIN. UPDATE (B)(6) 2020 -->THE CAUSE OF THE EVENT WAS THAT THE SALES REP DID NOT CONFIRM THE INITIAL OPERATION DATE WITH THE PHYSICIAN. THE PATIENT'S NAME WAS INFORMED TO THE DISTRIBUTOR BY THE PHYSICIAN. BASED ON THE NAME, THE ANTERIOR CERVICAL PLATE SYSTEM "VENTURE" CORRESPONDED TO THE HISTORY OF THE DISTRIBUTOR, AND THE DISTRIBUTOR CONTACTED THE SALES REP. THEREFORE, A "VENTURE" WAS PREPARED AS A REMOVAL DEVICE, BUT THE IMPLANT THAT WAS ACTUALLY IN THE PATIENT¿S BODY WAS "ZEVO", AND IT COULD NOT BE REMOVED SO IT HAD TO BRING IN THE "ZEVO" DEVICE AGAIN AND REMOVE IT. UPDATE (B)(6) 2020; THIS WAS THE REVISION SURGERY WHICH WAS PERFORMED ON (B)(6) 2020. AFTER BO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10435732 ↗

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