NA 1896-5075SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540202567), received between Oct 1, 2015 and Apr 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2018Out-Of-Box Failure

  THIS REPORT IS OUT OF BOX FAILURE. THE PHYSICIAN NOTICED THAT THERE WAS POWDER OF CUSHIONING ON THE SCREW. THE PHYSICIAN CONSIDERED IT CAN NOT BE USED, AND CHANGED TO THE OTHER DEVICE. THE PROCEDURE WAS COMPLETED USING OTHER DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7410159 ↗
• InjuryOct 1, 2015Insufficient Device Problem Information

  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: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 5116361 ↗