NEOFIX 900.353Recalls & reported problems
Neoortho Produtos Ortopédicos S/A. · 12-Hole Broad 4.5 LS Plate · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07898624861465), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2017Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
PLATE BREAKAGE 900.353, LOT 3653795, ABOUT 4 MONTHS AFTER ITS IMPLANTATION. PATIENT: (B)(6) - WITH FEMUR DIAPHYSIS FRACTURE, OPERATED ON (B)(6) 2017 AND PROGRESS TO PLATE BREAKAGE. PLATE REPLACEMENT SURGERY ON (B)(6) 2017. OTHER DEVICES USED: 903,110 LOT 3642537, 903.110 LOT:3622405, 903.112 LOT:3646846, 901.135 LOT:3637452, 901.136 LOT:3655115, 901.137 LOT: 3646905, 901.132 LOT: 3647568, 901.134 LOT: 3678916.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 6968769 ↗
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- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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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