Baby Gorilla/Gorilla Plating System P50-053-2528Recalls & reported problems
Paragon 28, Inc. · Baby Gorilla, Screw, Ø2.5 x 28mm, Locking, TiA · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889795019073), received between Nov 27, 2023 and Nov 27, 2023 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2023Break; Break
ON (B)(6) 2023, TWO BABY GORILLA LOCKING SCREWS (2.0MM X 36MM & 2.5MM X 28MM) WERE REPORTED BROKE DURING A FEMALE PATIENT'S NAVICULAR FRACTURE REVISION ON OCTOBER 27, 2023. IT WAS THE FIRST SET OF SCREWS THAT WERE PLACED IN THE PATIENT WHO WAS A COLLEGE ATHLETE. THE SCREWS WERE EXTRACTED USING A SPECIAL SCREW REMOVAL KIT AND DISCARDED. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS POSTPONED FOR MORE THAN 30 MINUTES. THIS IS REPORT 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212610 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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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