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OsteoMed 334-2426Recalls & reported problems

Osteomed LLC · 2.4mm x 26mm Fusion Screw · 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 00845694032476), received between Feb 19, 2019 and Feb 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

  • Migration1

Patient problems

  • Abdominal Pain1

Recent adverse event reports

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

  • InjuryFeb 19, 2019Migration

    ON (B)(4) 2019 OSTEOMED WAS NOTIFIED OF AN INCIDENT THAT OCCURRED WITH OUR 2.4MM X 26MM FUSION SCREW (P/N 334-2426). PER THE DISTRIBUTOR, THE CASE INVOLVED A NON-UNION. THE SURGERY WAS PERFORMED ON (B)(6) 2018. THE PATIENT RETURNED TO THE DOCTOR FOR A FOLLOW UP ON (B)(6) 2019. THE X-RAY TAKEN DURING THIS VISIT REVEALED MIGRATION OF THE FIXATION, AND THE PATIENT EXPRESSED SOME DISCOMFORT. THE PHYSICIAN PLACED THE PATIENT IN A CAST. THERE WAS ANOTHER FOLLOW-UP VISIT ON (B)(6) 2019. THE CAST REMAINED. THE REVISION SURGERY HAS BEEN SCHEDULED FOR FRIDAY, (B)(6) 2019. THE PHYSICIAN HAS RECOMMENDED THAT WE HAVE A BIGGER DIAMETER FIXATION SCREW.

    Patient problems: Abdominal Pain

    MAUDE report 8350154 ↗

Other Screw, fixation, bone devices

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