Zero-P VA 04.647.227SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034751214), received between Apr 18, 2022 and Jan 7, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Compatibility 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ZERO-P VA CAGE LRG LORDOTIC H7 PEEK AND SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A SPINAL FUSION PROCEDURE. DURING INSERTION OF THE INFERIOR SCREW, TWO ARTICULATING DRIVERS BROKE AND THE TITANIUM PORTION OF THE CAGE DETACHED. THE PIN AT THE ARTICULATING JOINT OF THE DRIVERS SHEARED OFF. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE, AND A STRAIGHT SHAFT DRIVER WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 10-MINUTE SURGICAL DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE PATIENT CONSEQUENCES. ALL DEVICE FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990033 ↗
• MalfunctionApr 18, 2022Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FUSION CAGE DEVICE WAS UNSTABLE IN ITS ROTATION AND COULD NOT BE USED. ACCORDING TO THE REPORT, TWO SCREW DEVICES WERE WASTED AS A RESULT. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) ZERO-P VA IMP 7MM HT LORDOTIC/LG-ST DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137467 ↗

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