OsteoMed 319-3014Recalls & reported problems
Osteomed LLC · 3.0mm x 14mm Cannulated Lag Screw · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694009805), received between Aug 24, 2018 and Aug 24, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2018Insufficient Device Problem Information
OSTEOMED WAS NOTIFIED OF AN INCIDENT RELATED TO A PATIENT. PER THE INFORMATION RECEIVED, THE PATIENT RECEIVED IMPLANTS ON (B)(6)2017. THE LISTING OF IMPLANTS WERE PROVIDED. THE IMPLANTS WERE REMOVED ON (B)(6)2018. NO ADDITIONAL INFORMATION WAS RECEIVED. FOLLOWING A SEARCH TO DETERMINE IF THE INCIDENT HAD BEEN PREVIOUSLY REPORTED, IT WAS DETERMINED THAT PRIOR NOTIFICATION WAS NOT IN OUR SYSTEM. THEREFORE, A COMPLAINT FOR EACH PART NUMBER REFERENCED HAS BEEN INITIATED TO DOCUMENT THIS INCIDENT AS AN ADVERSE EVENT.
Patient problems: No Information
MAUDE report 7815021 ↗MalfunctionAug 24, 2018Insufficient Device Problem Information
OSTEOMED WAS NOTIFIED OF AN INCIDENT RELATED TO A PATIENT. PER THE INFORMATION RECEIVED, THE PATIENT RECEIVED IMPLANTS ON (B)(6)2017. THE LISTING OF IMPLANTS WERE PROVIDED. THE IMPLANTS WERE REMOVED ON (B)(6)2018. NO ADDITIONAL INFORMATION WAS RECEIVED. FOLLOWING A SEARCH TO DETERMINE IF THE INCIDENT HAD BEEN PREVIOUSLY REPORTED, IT WAS DETERMINED THAT PRIOR NOTIFICATION WAS NOT IN OUR SYSTEM. THEREFORE, A COMPLAINT FOR EACH PART NUMBER REFERENCED HAS BEEN INITIATED TO DOCUMENT THIS INCIDENT AS AN ADVERSE EVENT.
Patient problems: No Information
MAUDE report 7815017 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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