GAMMA 3525-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540375735), received between Feb 27, 2020 and Oct 4, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AFTER THE INITIAL SURGERY, THE FRACTURE BECAME PSEUDOARTICULAR AND THE NAIL EVENTUALLY BROKE OFF. AFTER REMOVAL, IT WAS REPLACED WITH THA."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17867772 ↗
• InjuryNov 19, 2020Fracture; Fracture

  AS REPORTED; "ORIF FOR TROCHANTERIC FRACTURES OF THE FEMUR. THE NAIL BROKE BECAUSE THE BONES DID NOT HEAL."

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10870188 ↗
• InjuryFeb 27, 2020Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT WHO HAD LEFT LONG GAMMA OPERATION ON (B)(6) 2019. THE PATIENT FELT UNCOMFORTABLE AT THE SITE OF THE SURGERY, AND ON (B)(6) 2020, THE NAIL BREAK WAS CONFIRMED AT THE LAG SCREW INSERTION SITE. IT IS POSSIBLE THAT A LOAD WAS APPLIED WHEN USING THE STEP DRILL. AS A RESULT, THE NON-UNION OCCURRED. THE SIDE REDUCTION MAY HAVE BEEN SOMEWHAT POOR, OR THE PATIENT HAVE BEEN DRINKING SO MUCH THAT THIS MAY HAVE HAD AN EFFECT. A REVISION WAS MADE ON (B)(6)."

  Patient problems: Discomfort; Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 9766334 ↗