OsteoMed 302-2012Recalls & reported problems
Osteomed LLC · 2.0mm x 12mm Lag 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 00845694008051), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Material Fragmentation
IT WAS REPORTED: THE SURGEON DECIDED TO REMOVE A 2.0MM LAG SCREW THAT HE HAD IMPLANTED MOMENTS EARLIER. WHILE BACKING IT OUT, THE LAG SCREW BROKE NEAR THE MIDDLE (SEEMINGLY RIGHT WHERE THE THREADS ON THE SCREW BEGAN). BECAUSE OF THE LIMITED AMOUNT OF SPACE AND THE INABILITY TO GET THE ENTIRE BROKEN SCREW OUT, THE SURGEON HAD LESS SPACE TO PLACE SCREWS TO ACHIEVE HIS DESIRED OUTCOME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24821941 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-375Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.