Broad Plate, 3.5T MDS1101B14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812269024362), received between Jan 29, 2021 and Jan 29, 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 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.

• InjuryJan 29, 2021Break; Fracture; Break; Fracture

  THE SUBJECT PLATE WAS IMPLANTED, IN A PERI-PROSTHETIC HUMERAL REPAIR, AT OR AROUND (B)(6) 2020. THE PERI-PROSTHETIC REPAIR WAS TO IMPLANT A MDS1101B14 PLATE OVER A FRACTURE CAUSED BY A FALL AT THE DISTAL END OF THE PROSTHETIC STEM. THE PATIENT WAS "DOING FINE" AS REPORTED BY THE REVISION SURGERY SURGEON. AT OR AROUND THREE (3) WEEKS PRIOR TO THE SUBJECT REVISION SURGERY THE PATIENT FELL IN THE SHOWER WITHOUT ANY INDICATIONS OF TRAUMA TO THE BONE OR PLATE, AS REPORTED BY THE PATIENT. A WEEK PRIOR TO THE SUBJECT REVISION SURGERY THE PATIENT WOKE UP WITH PAIN AND UNABLE TO MOVE HER ARM. THE SUBJECT REVISION SURGERY WAS TO REMOVE THE BROKEN PLATE.

  Patient problems: Limb Fracture

  MAUDE report 11250854 ↗