GAMMA 3430-1400SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252274032), received between Nov 25, 2019 and Nov 25, 2019 — 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

Recent adverse event reports

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

• InjuryNov 25, 2019Break; Break

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF UNDERWENT SURGERY AT (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2018 TO TREAT A BROKEN FEMUR. THE DOCTOR PERFORMED THE SURGERY DURING WHICH TIME A ¿STRYKER PIN¿ WAS USED. THE PLAINTIFF ALLEGES THAT ON (B)(6) 2018, THE ¿PIN¿ BROKE. THE PLAINTIFF ALLEGES SHE UNDERWENT A SURGERY ON (B)(6) 2018 AT (B)(6) MEDICAL CENTER DURING WHICH TIME THE PIN WAS REMOVED AND PLAINTIFF WAS CONVERTED TO HAVING A TOTAL HIP REPLACEMENT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9372357 ↗