N/A CS 3955-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536170043), received between Mar 14, 2019 and Mar 14, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K161032); 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.

• InjuryMar 14, 2019Difficult to Insert; Difficult to Insert

  THE SURGEON WAS NOT ABLE TO FIXATE THE PLATE IN ITS ORIGINAL POSITIONING USING THE DRIVER AND HAD TO REMOVE IT ALONG WITH THE SCREWS AND ROD USED AND REPOSITION IT. ONCE THE PLATE WAS REPOSITIONED/ROTATED AND THE SURGEON WAS ABLE TO FIXATE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8420548 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161032. One submission often covers many models, so check the product and lot details in each record.

• Z-1126-2019 · Mar 8, 2019 · Terminated
  ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.