Elite EL-252013HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633021743), received between Sep 7, 2018 and Sep 25, 2018 — classified as 2 malfunctions.

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

• MalfunctionSep 25, 2018Break; Break

  THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT 20X20X20X20X20 4 LEGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905193 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON USED ELITE H IMPLANTS FOR A MIDFOOT FUSION PROCEDURE. POSTOPERATIVE X-RAYS SHOWED TWO BROKEN STAPLES. ONE STAPLE HAD ONE LEG BROKEN AT TOP OF THE SECOND BARB IN THE TALONAVICULAR (TN) JOINT AND THE OTHER STAPLE HAD ONE BROKEN LEG AT THE SHOULDER IN THE CALCANEOCUBOID (CC) JOINT. PATIENT HAD NO COMPLAINTS OF PAIN OR ANY SYMPTOMS. THERE WAS NO REVISION PROCEDURE PERFORMED. THIS REPORT IS FOR AN ELITE 25 X 13 X 20 X 20 X 20 X 20 MM (4 LEGS) H SHAPED IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7856624 ↗