Gorilla Plating System P53-103-L002Recalls & reported problems
Paragon 28, Inc. · MTP, 0 degree, Medium Plate, Left · 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 00889795009272), received between Jul 30, 2026 and Jul 30, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Fracture
It was reported that an MTP plate broke in half, revision surgery took place approximately 15 months post implantation due to patient experiencing pain ¿ existing hardware removed. Used P28 hardware used to complete revision. Screws are fine. Patient was not involved in any car accident, slip trip or fall but patient did have a non-union. The plate broke at the joint. Attempts have been made and not available information has been provided.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 50086184 ↗
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- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
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- PRECICE® Plating System LP4.5-PLF40Nuvasive 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 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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