Narrow Plate, 3.5T MDS1101N10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812269023556), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

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 18, 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.

• MalfunctionOct 4, 2021Break; Break

  IT WAS REPORTED VIA E-MAIL ON (B)(6) 2021 THAT A REVISION SURGERY WAS NEEDED TO REMOVE A BROKEN 10 HOLE NARROW PLATE. THE PLATE WAS BROKEN IN HALF AND SAFELY REMOVED FROM THE PATIENT. ON (B)(6) 2021 THE REPORTER STATED VIA PHONE CALL THAT THE PATIENT REPORTED SHE WOKE UP IN PAIN AS IF HER ARM WAS BROKEN. WHEN SHE GOT TO THE HOSPITAL IT WAS DISCOVERED THAT THE PLATE WAS BROKEN IN HALF. THERE ARE NO IMAGES OF THE EVENT. IT WAS DESCRIBED THE BROKEN PLATE WAS NOT PRE BENT AND WAS LOCATED BELOW THE SURGICAL NECK OF THE HUMERUS, BETWEEN THE OLECRANON. THE PLATE AND SCREWS WERE REMOVED WITH NO ISSUES. THERE ARE NO REPORTS OF DELAYS OR IMPACT ON THE PATIENTS OUTCOME AS A RESULT OF THE REVISION SURGERY. SUBJECT ITEMS WILL NOT BE RETURNED. THE REVISION SURGERY INCLUDED REMOVING THE BROKEN PLATE AND REPLACING IT WITH 2 3.5T NARROW PLATES, A 8 HOLE NARROW PLATE AND 10 HOLE NARROW PLATE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12572501 ↗