T2 1826-0003SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540378613), received between Oct 1, 2015 and Jun 7, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2021Migration; Migration

  IT WAS REPORTED: "DOCTOR SENT AN X-RAY SHOWING THAT THE T2 SCN END CAP WAS OUT OF THE NAIL AND IN THE PATIENT'S JOINT. THE REPORTER IS UNAWARE IF A REVISION IS SCHEDULED TO HAPPEN".

  Patient problems: Failure of Implant

  MAUDE report 11949734 ↗
• MalfunctionJan 21, 2021Fracture; Fracture

  AS REPORTED; "ABOUT 10 YEARS AGO, THE PATIENT INSERTED A T2 SUPRA CONDILLA NAIL AT ANOTHER HOSPITAL, AND OVER THE YEARS, THE END CAP HAD FALLEN OFF AND WAS IN THE JOINT. ADDITIONAL INFORMATION RECEIVED: DID THE LOOSE CAP HAD BEEN LOOSE IN THE JOINT DURING THE LAST 10 YEARS OR MORE RECENTLY? IT LOOSEN RECENT YEARS. ANY PLANS FOR MEDICAL INTERVENTION TO REMOVE THE END CAP? THE INFORMATION IS UNAVAILABLE, IF THE END CAP IS GOING TO REMOVE OR NOT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207338 ↗
• InjuryNov 15, 2018Detachment of Device or Device Component

  AT (B)(6) 2018, OPERATION WITH T2SCN WAS DONE. AFTER THE OPERATION, THE END CAP WAS CAME OUT AND THE MOST DISTAL CONDYLE SCREW WAS BACKED OUT. THEREFORE, AT (B)(6) 2018, THE END CAP AND CONDYLE SCREW WAS REMOVED AND NEW SAME DEVICES WERE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8075190 ↗
• InjuryOct 1, 2015Loss of or Failure to Bond

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 5116381 ↗