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OsteoMed 375-0002Recalls & reported problems

Osteomed LLC · Hemi Great Toe Implant, Small · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694011754), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Appears to Trigger Rejection1
  • Patient Device Interaction Problem1

Patient problems

  • Abdominal Pain1
  • Fever1
  • Pain1
  • Swelling1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2019Device Appears to Trigger Rejection; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

    FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT COMPLAINED OF SWELLING, PAIN AT THE SITE, AND EXPERIENCED FEVER. CULTURES DID NOT SHOW ANY INFECTION, BUT THE PHYSICIAN PRESCRIBED ANTIBIOTICS.

    Patient problems: Abdominal Pain; Fever; Pain; Swelling

    MAUDE report 8691793 ↗

Other PROSTHESIS, TOE, HEMI-, PHALANGEAL devices

All PROSTHESIS, TOE, HEMI-, PHALANGEAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.