Distal Radius Plate, Standard, Left, 3 Holes FDR 011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840118109932), received between Apr 20, 2016 and Oct 26, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123562); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE EVENT INCLUDED THE IMPLANTATION OF A PLATE THAT HAD EXCEEDED ITS SHELF LIFE. THE SHELF LIFE ON THE PACKAGING WAS INDICATED TO BE (B)(6) 2021. THE PLATE WAS IMPLANTED ON (B)(6) 2021. THEREFORE, THE PLATE HAD BEEN IMPLANTED 7 DAYS AFTER THE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701092 ↗
• MalfunctionApr 20, 2016Mechanics Altered

  THE SCREWS WOULD NOT LOCK IN 2 HOLES ON THE PLATE. DUE TO THE SCREWS NOT LOCKING TO THE PLATE, ALL OF THE HARDWARE WAS REMOVED. THIS DELAYED SURGERY BY OVER 15 MINUTES. AN ALTERNATE COMPANY'S ITEMS WERE USED TO STABILIZE THE WRIST UNTIL THE CORRECT PLATE SIZE COULD BE ORDERED FROM THE SAME ALTERNATE COMPANY. PATIENT RETUNED 3 DAYS LATER AND HAD THE PROCEDURE SUCCESSFULLY COMPLETED. THE DELAY IN SURGERY WAS ADDITIONAL INFORMATION RECEIVED ON 4/19/2016 DUE TO THE RECEIPT OF REPORT MW5060891 ON 4/18/2016.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5590436 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123562. One submission often covers many models, so check the product and lot details in each record.

• Z-0034-2022 · Sep 3, 2021 · Terminated
  Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
• Z-1314-2015 · Feb 16, 2015 · Terminated
  Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm