NA 03.647.994Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034720876), received between Nov 26, 2019 and May 7, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT TWO (2) 2.5 MM AWLS WITH SLEEVES HAD BROKEN SPRINGS. DAMAGED SPRINGS WERE NOTED DURING REPROCESSING THEREFOR THERE WAS NO SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM AWL WITH SLEEVE VARIABLE ANGLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791105 ↗
• MalfunctionMay 7, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT TWO (2) 2.5 MM AWLS WITH SLEEVES HAD BROKEN SPRINGS. DAMAGED SPRINGS WERE NOTED DURING REPROCESSING THEREFOR THERE WAS NO SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM AWL WITH SLEEVE VARIABLE ANGLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791040 ↗
• MalfunctionOct 15, 2020Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE INSPECTION OF 2.5 AWL, IT WAS DISCOVERED THE SPRING SLEEVE WOULDN'T THREAD PROPERLY, AND WAS DAMAGED WHEN TRYING TO RE-ENGAGE INTO THE SLEEVE. THERE WAS NO PATIENT CONSEQUENCES, OR SURGICAL DELAY INVOLVED. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1) MMSI DRIVER SHAFT FOR RED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684479 ↗
• MalfunctionNov 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSPECTION OF SET AT LOANERS DEPARTMENT. THE AWL WITH SLEEVE VARIABLE ANGLE WAS BROKEN INTO THREE (3) PIECES. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9375738 ↗

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