NA 04.647.834Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034751344), received between Mar 6, 2023 and Mar 6, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN ANTERIOR CERVICAL DISCECTOMY & FUSION CASE WAS BEING PERFORMED WITH THE PRODUCTS IN QUESTION. AFTER A RIGHT SIDED APPROACH AND DISCECTOMY UNDER MICROSCOPE SURGEON INSERTED A (04.647.126) 6MM TRIAL IMPLANT, FROM THE PROJECTED VIEW OF MICROSCOPE IMAGE I SUGGESTED A 7MM OR 8MM TRIAL. THE SURGEON STATED THEY NEVER PUT LARGER THAN A 6MM. THE SURGEON INSPECTED THE IMPLANT BOX AND CONFIRMED THE 6MM SELECTED. THE IMPLANT WAS INSERTED, AND SPACE WAS VISIBLE EITHER SIDE OF THE CAGE. THE SURGEON VOICED CONCERN THAT THE IMPLANT WAS TOO LOOSE I SUGGESTED A LARGER CAGE MAY PROVIDE A MORE EFFECTIVE RESULT. THE SURGEON PROCEEDED TO PREPARE THE CRANIALLY AIMED SCREW AND INSERTED A 14MM SCREW PAST THE LOCKING CLIP, THEN ATTEMPTED TO REPOSITION THE PLATE PORTION OF THE IMPLANT CAUSING IT TO DISCONNECT FROM THE PEEK PORTION ON THE IMPLANT. THE SURGEON THEN BACKED OUT THE INITIAL SCREW AND REMOVED IT SIMULTANEOUSLY ALONG WITH THE PLATE. THE ASSISTANT RETRIEVED THE PEEK PORTION OF THE CAGE WITH BAYONETED FORCEPS. THE SCREW STILL CONNECTED TO THE PLATE WAS LEFT TO BE ADDRESSED LATER AS THE SURGEON STATED IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485840 ↗

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