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Cancellous Screw, Cannulated 31457-65Recalls & reported problems

I.T.S. GmbH · Cancellous Screw, Cannulated, D=4.5mm, L=65mm, Var. Thread · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047293638), received between Mar 27, 2018 and Mar 27, 2018 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K060156); 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

Device problems

  • Break1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionMar 27, 2018Break; Break

    IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, A CANNULATED CANCELLOUS SCREW 4.5MM WITH THE LENGTH 65MM BROKE DUE TO UNKNOWN REASONS. SURGERY WAS COMPLETED WITH A DELAY OF MORE THAN 30 MINUTES. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 2 OF 2.

    Patient problems: No Information

    MAUDE report 7372518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060156. One submission often covers many models, so check the product and lot details in each record.

  • Z-1599-2026 · Jan 23, 2026 · Open, Classified
    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404
  • Z-1598-2026 · Jan 23, 2026 · Open, Classified
    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Fore

Other Screw, Fixation, Bone devices

All Screw, Fixation, Bone devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page