OsteoMed 333-2010Recalls & reported problems
Osteomed LLC · 2.0mm Subcondylar Plate, Locking · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00845694025034), received between Aug 28, 2018 and Aug 28, 2018 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
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.
MalfunctionAug 28, 2018Adverse Event Without Identified Device or Use Problem
ON 08/09/2018, OSTEOMED WAS NOTIFIED OF AN ADVERSE EVENT RELATED TO A PATIENT. PER THE INFORMATION RECEIVED, THE PATIENT RECEIVED IMPLANTS ON (B)(6) 2017. THE IMPLANTS WERE REMOVED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Information
MAUDE report 7823978 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-DRF32Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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