NA 03.647.971Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034720791), received between Oct 19, 2017 and Sep 13, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionSep 13, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  ADDITIONAL EVENT INFORMATION STATES THAT THE SCREW HAS BACKED OUT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218088 ↗
• MalfunctionDec 20, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 28, 2023, THE INSTRUMENTS WERE TAKEN OFF THE TRAY BY THE STERILIZATION TEAM BECAUSE THEY APPEARED BLUNT. THIS REPORT INVOLVES ONE (1) REMOVAL SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364713 ↗
• MalfunctionDec 20, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON NOVEMBER 28, 2023, THE INSTRUMENTS WERE TAKEN OFF THE TRAY BY THE STERILIZATION TEAM BECAUSE THEY APPEARED BLUNT. THIS REPORT INVOLVES ONE (1) REMOVAL SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364637 ↗
• MalfunctionApr 18, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM PORTUGAL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED, THAT ON (B)(6) 2023, THE SET ONLY HAD ONE SCREWDRIVER SHAFT. ONE WAS MISSING. IT WAS LATER DETERMINED, THAT THE MISSING SCREWDRIVER SHAFT WAS PRESENT, BUT WAS STUCK IN THE REMOVAL SCREWDRIVER. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED, THAT THE REMOVAL SCREWDRIVER WAS TWISTED FROM THE TIP. THIS REPORT IS FOR A REMOVAL SCREWDRIVER. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763348 ↗
• MalfunctionNov 13, 2018Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING EVALUATION IN THE EVALUATION DEPARTMENT, IT WAS DISCOVERED THAT THE REMOVAL SCREWDRIVER HAD A BROKEN/MISSING TIP. THERE WERE NO PROCEDURE OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8066667 ↗
• MalfunctionOct 19, 2017Break; Break

  IT WAS REPORTED THAT BOTH THE REMOVAL SCREWDRIVER AND THE INNER SHAFT FOR THE REMOVAL SCREWDRIVER HAVE BROKEN TIPS. THE DEVICE ISSUES WERE FOUND DURING INSPECTION OF THE EVALUATION SET. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REMOVAL SCREWDRIVER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6962381 ↗

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