uCentum CS 3020-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536014057), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2018Material 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7830276 ↗

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.