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OsteoMed 316-0119Recalls & reported problems

Osteomed LLC · .035 x 4 Double Trocar K-wire · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694031226), received between Jan 18, 2019 and Jan 18, 2019 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Post Operative Wound Infection1

Recent adverse event reports

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

  • InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem

    ON DECEMBER 27, 2018, OSTEOMED WAS NOTIFIED OF AN ISSUE WITH OUR .035 X 4" DOUBLE TROCAR K-WIRE. THE PHYSICIAN PERFORMED A CASE ON (B)(6) 2018 WHERE HE PUT A OSTEOMED SCREW IN A DIP FUSION LEFT INDEX. TWO (2) WEEKS LATER THE PATIENT HAS AN INFECTION ON THE OPERATIVE SITE.

    Patient problems: Post Operative Wound Infection

    MAUDE report 8260573 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

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