Zero-P VA 04.647.128SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034750743), received between May 24, 2019 and Mar 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DURING INSERTION OF ZERO PVA IMPLANTS, PLATE KEPT SEPARATING FROM PEEK PORTION. IMPLANT KEPT DISCONNECTING AND ASKED FOR NEW IMPLANT. SURGERY WAS DELAYED BY 5 MINUTES. NEW CAGE WAS OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495486 ↗
• MalfunctionMar 1, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 09-FEBRUARY-2024, THE ZERO P CAGE IN QUESTION SEPARATED WHEN IT WAS IMPLANTED. IT WAS REMOVED AND ANOTHER ONE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816195 ↗
• MalfunctionApr 29, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2021, THE ZERO-P VA IMPLANT BROKE DURING AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747843 ↗
• MalfunctionJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE SURGEON FELT THE CAGE WAS TOO COMPROMISED TO USE BECAUSE THE ZERO PROFILE VARIABLE ANGLE (VA) PLATE WAS NOT SECURE TO CAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING A NEW CAGE BUT WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: ZERO PROFILE VARIABLE ANGLE CAGE (PART PEEK 8, LOT L54638, QUANTITY 1). THIS REPORT IS FOR A ZERO-P VA IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672313 ↗
• MalfunctionMay 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNKNOWN DATE, THE PLATE ON THE ZERO-P IMPLANT LORDOTIC-STERILE KEPT SLIDING OFF WHEN THE SURGEON IMPACTED THE GRAFT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE SURGERY; TWO (2) ZERO VARIABLE ANGLE IMPLANT LORDOTIC STERILE AND TWO TITANIUM CERVICAL SPINE SCREW SELF DRILLING VA. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM (PART 04.647.836, LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) ZERO VARIABLE ANGLE IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641833 ↗
• MalfunctionMay 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNKNOWN DATE, THE PLATE ON THE ZERO-P IMPLANT LORDOTIC-STERILE KEPT SLIDING OFF WHEN THE SURGEON IMPACTED THE GRAFT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE SURGERY; TWO (2) ZERO VARIABLE ANGLE IMPLANT LORDOTIC STERILE AND TWO TITANIUM CERVICAL SPINE SCREW SELF DRILLING VA. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM (PART 04.647.836, LOT UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) ZERO VARIABLE ANGLE IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641832 ↗

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