N/A CS 3938-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04052536170029), received between Mar 24, 2020 and Mar 30, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150650); 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.

• InjuryMar 30, 2020Break; Break

  A REVISION WAS DONE 6 MARCH AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION WHEN THEY WERE TRYING TO REPLACE A ROD THE ROD REDUCER BROKE. REPORT 4 OF 5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9897258 ↗
• MalfunctionMar 30, 2020Break; Break

  A REVISION WAS DONE (B)(6) AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION WHEN THEY WERE TRYING TO REPLACE A ROD THE ROD REDUCER BROKE. REPORT 4 OF 5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9897257 ↗
• MalfunctionMar 24, 2020Difficult to Open or Close; Difficult to Open or Close

  A REVISION WAS DONE (B)(6) AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION WHEN THEY WERE TRYING TO REPLACE A ROD THE ROD REDUCER GOT STUCK ON THE ROD. THE SURGEON ENDED UP REMOVING THE ENTIRE CONSTRUCT. REPORT 5 OF 5.

  Patient problems: No Code Available

  MAUDE report 9875675 ↗
• InjuryMar 24, 2020Difficult to Open or Close; Difficult to Open or Close

  A REVISION WAS DONE 6 MARCH AS A RESULT OF SCREWS BACKING OUT. DURING THE REVISION WHEN THEY WERE TRYING TO REPLACE A ROD THE ROD REDUCER GOT STUCK ON THE ROD. THE SURGEON ENDED UP REMOVING THE ENTIRE CONSTRUCT. REPORT 5 OF 5.

  Patient problems: No Code Available

  MAUDE report 9875674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150650. One submission often covers many models, so check the product and lot details in each record.

• Z-1350-2020 · Dec 31, 2019 · Terminated
  Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw