Straight Plate, 2.0mm 21101-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09120034304361), received between Mar 2, 2018 and Jan 8, 2019 — classified as 1 injury, 2 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STRAIGHT PLATE, 2.0MM, 13-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2014. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: No Information

  MAUDE report 8225725 ↗
• MalfunctionJan 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A STRAIGHT PLATE, 2.0MM, 13-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2013. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013.

  Patient problems: No Information

  MAUDE report 8225436 ↗
• InjuryMar 2, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED ON UNKNOWN DATE DUE TO A BROKEN STRAIGHT PLATE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2017.

  Patient problems: No Information

  MAUDE report 7308988 ↗

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