NA 2358-3200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327346466), received between Sep 17, 2020 and Sep 23, 2020 — classified as 2 injuries.

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.

• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON TREATED A CHRONIC CHARCOT FOOT IN A MEDIAL COLUMN PROCEDURE AND PROVIDED THE FOLLOWING FEEDBACK: ¿CROWN DRILL AND BONE PLUG SEEMED INTUITIVE BUT IT WAS A LITTLE STRUGGLE.¿ ADDITIONAL INFO RECEIVED: "THE STRUGGLE WITH THE CROWN DRILL / BONE PLUG EXTRACTOR WAS IT WAS TOO BIG FOR THE PATIENT AND FRACTURED THE PROXIMAL PORTION OF THE 1ST MET HEAD. IT DID NOT ALTER THE OUTCOME OF THE CASE."

  Patient problems: Bone Fracture(s)

  MAUDE report 10576706 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON TREATED A CHRONIC CHARCOT FOOT IN A BOTH COLUMNS PROCEDURE ON A PATIENT THAT HAD PREVIOUSLY BEEN TREATED WITH AN EXTERNAL FIXATOR. HIS FEEDBACK INCLUDED THE FOLLOWING: "THE 1ST MET BONE PLUG WE REMOVED WAS TOO LARGE. I THINK PRIOR TO RE-INSERTING YOU SHOULD MEASURE THE DEPTH + CUT TO SIZE. TRYING TO TAMP THE LARGE PLUG BACK IN DESTROYED THE CARTILAGE OF THE JOINT.¿ [PROVIDED AS A COMMENT ON ANY DISSATISFACTION WITH THE PRODUCTS AND PROCEDURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10550775 ↗