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OsteoMed 211-1604Recalls & reported problems

Osteomed LLC · 1.6mm x 4mm AUTO-DRIVE Screw · 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 00845694002363), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 14, 2021Material Fragmentation; Material Fragmentation

    DURING THE CRANIOTOMY PROCEDURE, THE SCREW BROKE WHILE SCREWING IN AND A TINY PIECE WAS LEFT IN THE PATIENT AND NOT REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE IS NOT RETURNING AS IT WAS LOST BY THE FACILITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13003260 ↗

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.