OSTEOSET 84000104Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420123817), received between Jan 20, 2026 and Jan 20, 2026 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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 20, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "PAIN IN THE LEFT HEEL CAUSED BY A FALL AND INABILITY TO STAND FOR 3 HOURS". PHYSICAL EXAMINATION: SWELLING OF THE LEFT HEEL AND ANKLE, OBVIOUS TENDERNESS IN THE HEEL AND LATERAL MALLEOLUS, ACCEPTABLE FLEXION AND EXTENSION OF THE ANKLE JOINT, NORMAL MUSCLE STRENGTH AND MUSCLE TONE IN THE DISTAL LIMB, NORMAL BLOOD SUPPLY TO THE EXTREMITIES, AND NO OBVIOUS ABNORMALITIES IN SENSATION AT THE EXTREMITIES. AUXILIARY EXAMINATION: (b)(6) 2025 X-RAY: MULTIPLE FRACTURES OF THE LEFT CALCANEUS, AND THE DISTAL END OF THE LEFT LATERAL MALLEOLUS IS IRREGULAR. THE DIAGNOSIS RESULTS: 1. MULTIPLE FRACTURES OF THE LEFT CALCANEUS. 2. HYPERTENSIONDIAGNOSIS AND TREATMENT PROCESS AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL, RELEVANT EXAMINATIONS AND TESTS WERE COMPLETED. SYMPTOMATIC TREATMENT SUCH AS PAIN RELIEF, SWELLING REDUCTION AND THROMBOSIS PREVENTION WAS PROVIDED TO THE PATIENT. AFTER THE SWELLING SUBSIDED, AN OPEN REDUCTION AND BONE GRAFTING INTERNAL FIXATION SURGERY FOR THE LEFT CALCANEAL FRACTURE WAS PERFORMED UNDER INTRAVENOUS ANESTHESIA ON (b)(6) 2025. DURING THE OPERATION, BONE GRAFT REPLACEMENT MATERIALS WERE USED TO FILL THE

  Patient problems: Bacterial Infection

  MAUDE report 24121853 ↗