NA 04.647.876Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034751429), received between Oct 26, 2018 and Apr 18, 2022 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FUSION CAGE DEVICE WAS UNSTABLE IN ITS ROTATION AND COULD NOT BE USED. ACCORDING TO THE REPORT, TWO SCREW DEVICES WERE WASTED AS A RESULT. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 16MM DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137470 ↗
• InjuryOct 26, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, A REVISION ANTERIOR CERVICAL FUSION WAS PERFORMED DUE TO FAILURE TO LOCK OF A CERVICAL SPINE SELF-TAPPING ZERO PROFILE VARIABLE ANGLE (VA) SCREW. THE HARDWARE WAS IMPLANTED IN (B)(6) 2016. ON AN UNKNOWN POST-OPERATIVE DATE, A YEAR AFTER INITIAL IMPLANTATION, IT WAS DISCOVERED THAT THE SCREW HAD BACKED OUT FROM THE ZERO PROFILE VARIABLE ANGLE PLATE. THE SCREW WAS SUCCESSFULLY REMOVED WITH NO HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE: ZERO-P VA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 3.7MM TITANIUM (TI) CERVICAL SPINE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8010380 ↗

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