Zero-P VA 04.647.217SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034751139), received between Jan 17, 2018 and Jan 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT ONE (1) ZERO-P VARIABLE ANGLE (ZPVA) IMPLANT BROKE INTO TWO CLEAN PARTS WHEN THE ZPVA SPACER PLATE AND THE PEEK (POLYETHERETHERKETONE) SPACER SEPARATED DURING AN INITIAL IMPLANT AT THE C6 AND C7 LEVELS ON (B)(6) 2017. THE IMPLANT SEPARATED WHEN THE SURGEON WAS TAPPING IT WITH AN UNKNOWN INSERTER. THERE WAS NO DAMAGE TO THE PATIENT UPON SEPARATION OF THE ZERO-P IMPLANT. BOTH SEPARATED PARTS WERE REMOVED FROM THE PATIENT WITHOUT ANY INCIDENCE AND WAS FURTHER REPLACED BY ANOTHER ZERO-P IMPLANT WITH THE SAME PART NUMBER THAT WAS AVAILABLE FOR USE AT THE TIME. THERE WAS NO REPORTED SURGICAL DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION AND THERE WERE NO ADDITIONAL MEDICAL INTERVENTIONS REQUIRED TO COMPLETE THE SURGERY. CONCOMITANT DEVICES REPORTED: INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT 7MM HEIGHT PARALLEL/LARGE-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201936 ↗

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