NA 242.06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982167873), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.

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

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.

• InjuryNov 16, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION FIXATION AND BONE GRAFTING. PATIENT HAS AN OPEN REDUCTION OF THE RIGHT BONE MID-SHIFT ULNA AND RADIUS FRACTURE. THE SURGERY WAS ON (B)(6) 2021. THEY WERE FIXED WITH A SIX HOLE ONE-THIRD TUBULAR PLATE ON THE RADIUS AND A SIX HOLE ON THE ULNA. THE ULNA WENT ON ONTO A NONUNION AND THE PLATE BROKE AT THE FRACTURE SITE. THE PATIENT RETURNS TO THE OPERATING ROOM ON (B)(6) 2021, FOR REVISION FIXATION AND BONE GRAFTING. THE BROKEN PLATE AND SCREW WERE REMOVED FROM THE ULNA WITH NO DIFFICULTY. ALL HARDWARE WAS REMOVED. ONLY THE PLATE WAS BROKEN AND 5 OF THE 2.7 MM CORTEX SCREWS WERE REMOVED. FRACTURE SITE WAS CLEANED UP AND BONE GRAFTED AND A NEW PLATE AND SCREW WERE IMPLANTED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) QUARTER-TUBULAR PL COLLAR 6 HOLES/47. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12820104 ↗