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OsteoMed 319-1020Recalls & reported problems

Osteomed LLC · 2.0mm x 10 Degree ExtremiFuse Implant · Class 2

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 00845694052191), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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

  • Loss of or Failure to Bond1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionOct 18, 2018Loss of or Failure to Bond

    ON (B)(6) 2018, OSTEOMED WAS NOTIFIED OF AN ADVERSE EVENT RELATED TO THE 2.0MM X 10 EXTREMIFUSE IMPLANT (P/N (B)(4)). PER THE INFORMATION RECEIVED, THE DISTAL PART OF THE IMPLANT DID NOT CATCH PROPERLY, SO A SURGERY WAS PERFORMED ON (B)(6) 2018 TO REMOVE IT.

    Patient problems: No Information

    MAUDE report 7981393 ↗

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.