Zero-P VA 04.647.239SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034751313), received between Nov 1, 2018 and Nov 1, 2018 — 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 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.

• MalfunctionNov 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH ONE (1) ZERO-PROFILE VARIABLE ANGLE IMPLANT INTO C4-C5 USING AN INSERTION DEVICE. UPON IMPACTION INTO THE DISC SPACE, THE PLATE SEPARATED FROM AN UNKNOWN PEEK SPACER DURING AN ANTERIOR CERVICAL FUSION. THE SURGEON REMOVED BOTH COMPONENTS AND THE SURGICAL TECH REATTACHED THE PLATE TO THE SPACER ON THE BACK TABLE. THE SURGEON THEN ATTEMPTED TO IMPLANT THE SAME DEVICE A SECOND TIME. AT FIRST IT SEEMED TO BE FINE, BUT AFTER IMPLANTING AN UNKNOWN 16MM SCREW, THE SURGEON AGAIN DISCOVERED THAT THE PLATE WAS NOT SECURELY ATTACHED TO THE PEEK SPACER. THE SURGEON REMOVED THE UNKNOWN SCREW, PLATE AND THE UNKNOWN PEEK SPACER AND REQUESTED ANOTHER IMPLANT TO BE OPENED. THE SURGEON THEN IMPLANTED THE NEW IMPLANT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCE WAS REPORTED. CONCOMITANT DEVICES REPORTED: INSERTION DEVICE (PART# 03.647.963, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT 9MM HEIGHT CONVEX/LARGE-STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027963 ↗

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