Baby Gorilla/Gorilla Plating System P99-191-LR10Recalls & reported problems
Paragon 28, Inc. · Gorilla. R3CON, Long Driver Solid, HX10 X 83MM SS · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889795054548), received between May 18, 2026 and Jul 2, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Fracture
IT WAS REPORTED THAT DURING SURGERY THE DRIVER TIP BROKE WHILE TIGHTENING A SCREW. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT, THERE WAS NO DELAY IN THE PROCEDURE, AND THE SURGERY WAS COMPLETED USING A SECOND DRIVER FROM THE SET. THE PATIENT HAD NO CONSEQUENCES OR IMPACT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692857 ↗MalfunctionMay 18, 2026Fracture
IT WAS REPORTED THAT THREADS ON A DRIVER TIP WERE FOUND TO BE CHIPPED OFF DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ONE EXPERIENCED ANY CLINICAL SIGNS/SYMPTOMS AS A RESULT OF THE DAMAGED DRIVER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25204285 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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