Fine Osteotomy system - Proximal tibia 015-410-004Recalls & reported problems
Laboratoires Bodycad Inc · Tibial plate, Cortical Locking Screws, Cortical compression Screws, cancellous Compression Screws and disposable instrumentation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00688346002287), received between Oct 26, 2024 and Apr 6, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
- Fracture1
Patient problems
- Implant Pain1
- Medical device site infection1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Fracture
DURING A HARDWARE REMOVAL PROCEDURE, TWO BONE SCREWS WERE FOUND TO BE FRACTURED. THE EVENT WAS IDENTIFIED INTRAOPERATIVELY DURING EXPLANTATION OF A PREVIOUSLY IMPLANTED SYSTEM. IMAGING PRIOR TO REMOVAL HAD NOT CLEARLY INDICATED BREAKAGE. SOME SCREW FRAGMENTS REMAINED IN SITU. THE PROCEDURE WAS OTHERWISE COMPLETED, AND THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793545 ↗InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT DEVELOPED A POSTOPERATIVE SURGICAL SITE INFECTION REQUIRING READMISSION AND A WASHOUT PROCEDURE AFTER THE USE OF A BODYCAD FINE OSTEOTOMY PATIENT-SPECIFIC PLATE. THERE IS NO CONFIRMED EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION. THE EVENT IS UNDER INTERNAL INVESTIGATION, AND ADDITIONAL INFORMATION WILL BE PROVIDED AS AVAILABLE.
Patient problems: Medical device site infection
MAUDE report 23669236 ↗MalfunctionOct 26, 2024Connection Problem; Connection Problem
A HIGH TIBIAL OSTEOTOMY (HTO) WAS PERFORMED USING THE FINE OSTEOTOMY SYSTEM APPROXIMATELY 5 MONTHS AGO, RESULTING IN A NONUNION, INDICATING A LACK OF PROPER BONE HEALING. THE LIMB NOW SHOWS A VARUS DEVIATION, ALONG WITH HARDWARE LOOSENING.
Patient problems: Implant Pain
MAUDE report 20540231 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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