OSTEOSET 84000611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420133687), received between Nov 9, 2021 and Aug 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN "OPEN REDUCTION AND INTERNAL FIXATION+BONE GRAFTING SURGERY" DUE TO A FRACTURE OF THE LEFT TIBIAL PLATEAU. AFTER THE SURGERY, A SMALL AMOUNT OF EXUDATE APPEARED IN THE WOUND ON 7 DAYS LATER, SHOWING A LIGHT YELLOW TRANSPARENT LIQUID. SUBSEQUENTLY, THE WOUND EXUDATE GRADUALLY INCREASED, SHOWING A YELLOW PUS COLOR ACCOMPANIED BY THE DISCHARGE OF THE ARTIFICIAL BONE. IT IS CONSIDERED THAT THERE IS A REJECTION REACTION AFTER THE ARTIFICIAL BONE IMPLANTATION. THE PATIENT IS CURRENTLY INFECTED WITH THE WOUND DUE TO REJECTION REACTION, AND IT IS REPORTED TO THE HOSPITAL, SELECT SENSITIVE DRUGS TO RESIST INFECTION BASED ON SECRETION CULTURE, AND STRENGTHEN SYMPTOMATIC TREATMENT SUCH AS DRESSING CHANGES.

  Patient problems: Bacterial Infection

  MAUDE report 17504726 ↗
• MalfunctionNov 9, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE BEADS DID NOT SET AS EXPECTED AND THEY WERE WASTED/DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782713 ↗