T2 ALPHA 2337-1138SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327289077), received between Sep 15, 2020 and Mar 4, 2022 — classified as 1 injury, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED: "ONE MONTH POSTOPERATIVE EXAMINATION SHOWED BACKOUT OF THE ADVANCED LOCKING SCREW. AT THE MOMENT, NO ADDITIONAL INFORMATION IS AVAILABLE AND NO REVISION IS PLANNED."

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 13674195 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN USA. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF FEMORAL FRACTURES WITH THE FEMORAL NAIL PIRIFORMIS FOSSA (PF) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿. THIS STUDY INCLUDES RESEARCH DONE ON 18 PATIENTS (19 CASES) REQUIRING SURGERY BETWEEN THE PERIOD MARCH 2019 AND OCTOBER 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DELAYED UNION DUE TO INFECTION WHICH WAS RESOLVED BY REVISION. THE REPORT STATES: ¿THERE WERE 3 DELAYED UNIONS, WHICH WERE DEFINED AS THE ABSENCE OF RADIOGRAPHIC PROGRESSION OF HEALING OR THE INSTABILITY OF A FRACTURE UPON CLINICAL EXAMINATION BETWEEN 4 AND 6 MONTHS AFTER INJURY. ONE WAS DUE TO INFECTION OF UNION THAT WAS NOT DEVICE RELATED, WHICH WAS RESOLVED WITH REVISION SURGERY (RIGHT FEMORAL

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 10538666 ↗