Zero-P VA 04.647.115SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034750637), received between Feb 24, 2023 and Feb 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K112068); 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.

• MalfunctionFeb 24, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ITEM BROKE DURING INSERTION AFTER BEING PACKED WITH BONE. THE PEEK COMPONENT SEPARATED FROM THE GREEN PLATE. THE IMPLANT INSERTER WAS PROPERLY CONNECTED TO THE PLATE AT THE TIME OF INSERTION. THERE WAS A FIVE-MINUTE DELAY RELATED TO THE EVENT. THE SITE USED BACKUP STERILE IMPLANTS TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED, AND THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ZERO-P VA IMPLANT 5MM HEIGHT PARALLEL-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434902 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica