Zero-P VA 04.647.138SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034750828), received between Aug 1, 2018 and Mar 25, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS PERFORMING A C3-C7 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT LEVELS C3-4, C4-5, AND C5-6. WHEN THE SURGEON IMPLANTED A ZERO-P VA IMPLANT AT C6-7, IT WAS NOTICED THAT SOMETHING APPEARED WRONG WITH THE CAGE. THE SURGEON PUT IN A 3.7 CERVICAL SPINE SCREW 16MM AND A 3.7 CERVICAL SPINE SCREW 18MM TO LOCK IT IN PLACE PER THE RECOMMENDED TECHNIQUE, BUT WAS STILL NOT SATISFIED. THE SURGEON COMMENTED THAT THE CAGE HAD SEPARATED FROM THE PLATE. HE REMOVED THE CAGE, PLATE AND TWO (2) SCREWS AND REQUESTED DIFFERENT IMPLANTS. A NEW IMPLANT WAS OPENED AND THE PROCEDURE WAS CONCLUDED AS PLANNED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A ZERO-P VA IMPLANT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449014 ↗
• MalfunctionFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377818 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A C4-C7 ANTERIOR CERVICAL FUSION PROCEDURE. DURING THE PROCEDURE, THE ZERO-P VARIABLE ANGLE (VA) IMPLANT 8MM HEIGHT CONVEX-STERILE WAS INSERTED AT THE C4-C5 LEVEL. UPON INSERTION WITH THE INSERTION DEVICE, THE PLATE DISENGAGED FROM THE PEEK SPACER. THE SURGEON WAS UNABLE TO COMPLETELY RE-ENGAGE THE PLATE TO THE IMPLANT AFTER NUMEROUS ATTEMPTS. A NEW ZERO-P VA IMPLANT WAS REQUESTED AS THE SURGEON WAS UNCOMFORTABLE WITH TRYING TO FORCE THE IMPLANT ON. UPON REMOVING THE ZERO-P VA IMPLANT FROM THE STERILE FIELD, THE SALES CONSULTANT WAS ABLE TO DISENGAGE THE IMPLANT COMPLETELY WITH CONSIDERABLE FORCE. THE PLATE SEEMED TO BE STUCK HALFWAY DOWN THE TRACK ON THE PEEK SPACER. A NEW ZERO-P VA OF THE SAME SIZE WAS IMPLANTED WITH NO ISSUES. THE INNER SHAFT FOR EXTRACTION SCREWDRIVER WAS REPORTEDLY BROKEN, AND THE FRAGMENT IS STILL LOCATED INSIDE OF A TITANIUM CERVICAL SELF RETAINING SCREW THAT WAS NOT IMPLANTED INTO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE/S REPORTED: INSERTION DEVICE (PART# 03.647.963,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739936 ↗

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