Baby Gorilla®/Gorilla® Plating System P53-402-R101Recalls & reported problems
Paragon 28, Inc. · Lateral TTC Plate, Standard, Right · Class 2
All models of Baby Gorilla/Gorilla Plating System (10)
Data updated Oct 18, 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 00889795053206), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2020Break
IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY WITH A PARAGON 28 SILVERBACK GORILLA LATERAL TTC PLATE ON (B)(6) 2020. POST-OPERATIVELY THE PLATE WAS FOUND BROKEN, AND THE PATIENT WAS REPORTED TO HAVE STEPPED INTO A HOLE DURING RECOVERY. AS OF THE REPORTING DATE, THE PATIENT'S ANKLE IS OVER 50% FUSED BASED ON CT SCANS. THERE IS NO LOOSENING OF SCREWS IN THE TALUS AND CALCANEOUS. THERE IS NO REVISION SURGERY PLANNED FOR THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10291832 ↗
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- PRECICE® Plating System LP4.5-PLF4BNuvasive 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-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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