Phantom Fibula Nail SystemRecalls & reported problems across all models
Paragon 28, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Phantom Fibula Nail System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of Phantom Fibula Nail System by Paragon 28, Inc. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2025 and Dec 11, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Phantom Fibula Nail System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 13, 2025Open, Classified
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
Z-0871-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Phantom Fibula Nail System problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
Phantom Fibula Nail System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Phantom® Fibula Nail System P36-128-130R-SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall2 reports
- Phantom® Fibula Nail System P36-128-130L-SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent Phantom Fibula Nail System adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING NAIL INSERTION, THE PROXIMAL FIXATION WAS ENGAGED USING AN ACTUATION DRIVER AND AS THE DRIVER WAS TURNED TO DEPLOY THE FIXATION, THE FIBULA FRACTURED. THE NAIL REMAINS IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 23779184 ↗MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE NAIL DID NOT CONNECT PROPERLY TO THE NAIL GUIDE. THE CASE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT NAIL; DELAY OF SURGERY WAS LESS THAN 30 MINUTES. NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23304161 ↗MalfunctionOct 15, 2025Unintended Movement; Unintended Movement
THE FIBULAR NAIL DID NOT SIT FLUSH OR TIGHTEN PROPERLY TO THE OUTRIGGER WHEN CORRECTLY POSITIONED. THIS RESULTED IN A DELAY OF APPROXIMATELY 30 MINUTES TO TROUBLESHOOT THE PROBLEM. THE NAIL WAS REMOVED FROM THE PATIENT AND UPSIZE TO THE NEXT SIZE NAIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303569 ↗
Other Paragon 28, Inc. products
All Paragon 28, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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