Skip to content

GAMMA 3520-0300SRecalls & reported problems

Stryker GmbH · Long Nail Kit R1.5, Ti, LEFT · Class 2 · Implant

All models of GAMMA (249)

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 04546540375582), received between Jun 4, 2018 and Jun 4, 2018 — 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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Failure of Implant1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 4, 2018Break

    THE PATIENT UNDERWENT GAMMA3 SURGERY ON (B)(6) 2016. THE PATIENT WAS IN A STATE OF NONUNION FOR APPROXIMATELY ONE YEAR AND A HALF AFTER SURGERY, BUT SHE WAS LIVING AS IT WAS BECAUSE SHE HAD NO PROBLEM IN HER DAILY LIFE. HOWEVER, SHE COMPLAINED A PAIN OF FEMUR IN (B)(6) 2018 AND THE NAIL BREAKAGE WAS CONFIRMED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

    Patient problems: Failure of Implant; Pain

    MAUDE report 7567122 ↗

Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices

All ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page