NA 04.647.874Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034751405), received between Aug 13, 2021 and Oct 15, 2021 — classified as 2 malfunctions.

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

• MalfunctionOct 15, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN INSERTING A SCREW INTO THE ZERO P VARIABLE ANGLE (VA) IMPLANT A THIN METAL RING APPEARED TO UNSPOOL WHEN INSERTION TORQUE WAS APPLIED TO THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 14MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641559 ↗
• MalfunctionAug 13, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN INSERTING A SCREW INTO THE ZERO P VARIABLE ANGLE (VA) IMPLANT A THIN METAL RING APPEARED TO UNSPOOL WHEN INSERTION TORQUE WAS APPLIED TO THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 14MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319394 ↗

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