EVOLUTION EFSAN2PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EFSAN2PL1), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 injury.

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 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.

• InjuryDec 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY,THE PATIENT (ASSUMING WE ARE TALKING ABOUT A SIZE 2 SET OF IMPLANTS) WAS SMALL FRAMED FEMALE. SALES REP IS TOLD THAT EXPOSURE WAS EXTREMELY DIFFICULT AND DR STRUGGLED THRU THE ENTIRE CASE. THE CEMENT TECHNIQUE WAS POOR AND THERE WAS A CONSIDERABLE AMOUNT OF LIQUID AND FLUIDS PRESENT IN THE WOUND DURING APPLICATION OF THE CEMENT. THE CASE WAS A BILATERAL SURGERY. HE BELIEVES BOTH DEVICES REQUIRED REVISION IN A SHORT PERIOD OF TIME FOLLOWING THE PRIMARY CASE. IT IS NOT CONFIRMED THAT THE DEVICES HAVE BEEN ALREADY REVISED. NO PART NUMBERS OR LOT NUMBERS FOR THE DEVICES HAVE BEEN RECEIVED HOWEVER, IT IS INDICATED THAT THE SET OF NITRX IMPLANTS ARE SIZE NUMBER 2. THE EVENT REGARDING THE DEVICES IMPLANTED ON PATIENT'S RIGHT SIDE ARE CAPTURED UNDER MICROPORT ORTHOPEDICS GROUP NUMBER:(B)(4).

  Patient problems: Fluid Discharge

  MAUDE report 15905596 ↗