NA 705803Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327409628), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  SURGEON PERFORMED A TIBIO-TALAR JOINT FUSION WITH USE OF AN ANTERIOR CP PLATE. HIS FEEDBACK INCLUDED THE FOLLOWING: ¿CP REAMER IS A LITTLE LARGE WITH ANTERIOR CORTEX AND WE BROKE IT OUT BUT CP PLATE STILL WORKED. JUST SOMETHING TO WATCH OUT FOR.¿ [PROVIDED AS A COMMENT ON ANY DISSATISFACTION WITH THE PRODUCTS AND PROCEDURE] ¿CP REAMER IS VERY LARGE.¿ [INDICATED AS AN IDENTIFIED AREA FOR IMPROVEMENT]. "CP REAMER.¿ [REPORTED AS AN OBSERVED DEFICIENCY AND/OR COMPLICATION]. ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE: "[...] YOU HAVE TO REAM DOWN A GOOD AMOUNT AND IN MY CASE THE CORTEX WASN¿T LARGE ENOUGH TO ACCEPT THIS DEPTH CAUSE THE REAMER TO GO INTO THE CANAL. NO DELAY AND WE STILL COMPLETED THE CASE AS DESIRED."

  Patient problems: Limb Fracture

  MAUDE report 10649526 ↗