T2 1851-1036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540647474), received between Dec 28, 2020 and Dec 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryDec 28, 2020Fracture; Fracture

  "IT WAS REPORTED VIA MEDWATCH # (B)(4): "ON (B)(6) 2020, PATIENT SUSTAINED INJURY WHILE PLAYING ON MONKEY BARS AT SCHOOL. FELL SUSTAINING A PER-PROSTHETIC RIGHT PROXIMAL FEMUR FRACTURE. FRACTURE WAS IMMEDIATELY DISTAL TO THE RETAINED FEMORAL PLATE. PATIENT BROUGHT TO THE OPERATING ROOM THE NEXT DAY AND UNDERWENT REMOVAL OF BLADE PLATE IMPLANT AND SCREWS, RIGHT PROXIMAL FEMUR AND OPEN REDUCTION OF RIGHT PROXIMAL FEMUR FRACTURE WITH INSERTION OF INTRAMEDULLARY NAIL WITH PROXIMAL AND DISTAL LOCKING SCREWS. DISCHARGED NEXT DAY. PATIENT DOING WELL UNTIL ONE MONTH LATER. PATIENT WAS SHOOTING BASKETS AT SCHOOL WHEN HE FELT A POP IN HIS RIGHT LEG AND IMMEDIATELY FELL AND HAD SIGNIFICANT PAIN. X-RAYS SHOWED FRACTURED INTRAMEDULLARY NAIL THROUGH THE DISTAL OF THE 2 PROXIMAL LOCKING SCREW HOLES. THE ROD BROKE IN THAT POSITION, BUT THE BONE GAVE WAY THROUGH THE PREVIOUS AREA OF FRACTURE. AFTER A PLAN WAS MADE TO REMOVE THE BROKEN FEMORAL NAIL AND THEN TREAT THE FRACTURE WITH A STANDARD ADULT BLADE PLATE AND APPROPRIATE IMPLANTS AND EQUIPMENT WERE OBTAINED, PATIENT WAS BROUGHT TO THE OPERATING ROOM TO UNDERGO REMOVAL OF THE BROKEN IMPLANT AND FIXATION OF HIS RIGHT PROXIMAL FEMUR FRACTURE WITH A

  Patient problems: Failure of Implant; Fall; Limb Fracture

  MAUDE report 11076840 ↗