N/A CS 3825-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04052536081202), received between Nov 30, 2016 and Sep 26, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K123717); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 26, 2019Material Fragmentation; Material Fragmentation

  WE RECEIVED A COMPLAINT THAT THE SCREWDRIVER HAD SHEARED OFF DURING THE CASE. WHEN THE PRODUCT WAS RECEIVED BACK WE DISCOVERED THE TIP HAD BROKEN OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9124031 ↗
• InjuryJun 28, 2019Material Fragmentation; Material Fragmentation

  THE SURGEON WAS NOT ABLE TO SUCCESSFULLY IMPLANT THE SCREW; TWO SCREWDRIVERS BROKE WHILE TRYING BUT REMAINED INTACT. HE DECIDED TO REMOVE THE SCREW AND BROKE ANOTHER SCREWDRIVER TRYING TO DO SO AND SEVERAL PIECES OF METAL BROKE OFF FROM THE SCREWDRIVER BUT WERE RECOVERED AND RETURNED ALONG WITH THE DRIVERS. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING A ROD AND LOCKING SCREW. REPORT 3/5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745565 ↗
• InjuryJun 28, 2019Material Fragmentation; Material Fragmentation

  THE SURGEON WAS NOT ABLE TO SUCCESSFULLY IMPLANT THE SCREW; TWO SCREWDRIVERS BROKE WHILE TRYING BUT REMAINED INTACT. HE DECIDED TO REMOVE THE SCREW AND BROKE ANOTHER SCREWDRIVER TRYING TO DO SO AND SEVERAL PIECES OF METAL BROKE OFF FROM THE SCREWDRIVER BUT WERE RECOVERED AND RETURNED ALONG WITH THE DRIVERS. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING A ROD AND LOCKING SCREW. REPORT 2/5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745550 ↗
• MalfunctionNov 30, 2016Break; Break

  SCREWDRIVER TIP BROKE OFF WHILE IN SURGERY, WAS NOT ABLE TO BE RETRIEVED, AND REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6135004 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123717. 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.