Zero-P VA 04.647.236SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034751283), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANTERIOR CERVICAL FUSION, A 6MM LARGE ZERO P VARIABLE ANGLE (VA) IMPLANT PLATE AND INTERBODY WERE SEPARATED WHILE IMPLANTING AT C6-7. THE TWO PIECES WERE REASSEMBLED THRICE ON THE FIELD AND THE IMPLANTATION WAS REATTEMPTED BUT STILL SEPARATED AGAIN. ANOTHER IMPLANT WAS REQUESTED BY THE SURGEON FEARING THAT SOMETHING WAS DAMAGED WITH THE PREVIOUS PLATE. IN THE CASE OF PATIENT ANATOMY, THE SURGEON THEN REQUESTED A 6MM STANDARD ZERO P VARIABLE ANGLE (VA) PLATE, WHICH WAS OPENED AND IMPLANTED AS PLANNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT 6MM HEIGHT CONVEX/LARGE-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311757 ↗

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