MINI IC2516Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327362091), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120493); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2021Fracture; Fracture

  AS REPORTED: "I STARTED WORKING WITH THIS HIGH VOLUME DPM ABOUT 3 MONTHS AGO. IT WAS BROUGHT TO MY ATTENTION THAT 2 MAYBE 3 REVISIONS ARE NEEDED NOW ON A CHEVRON OSTEOTOMY THAT THE SURGEON USED OUR MINI CANNULATED 2.5 HEADED SCREWS. REPORTED THAT SOME OF THE SCREWS HAVE BROKEN."

  Patient problems: Failure of Implant

  MAUDE report 11168091 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120493. One submission often covers many models, so check the product and lot details in each record.

• Z-2679-2014 · Apr 25, 2013 · Terminated
  Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System