MULTILOC 04.016.315SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982089311), received between Dec 12, 2017 and Dec 12, 2017 — classified as 1 injury.

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 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN AN ATTEMPT TO DO AN ANKLE ARTHRODESIS, A MULTILOC HUMERAL NAIL AND LOCKING SCREWS WERE IMPLANTED TO MIMIC AN ARTHRODESIS NAIL ON A LEFT DISTAL TIBIA (AN OFF-LABEL USE AS DESCRIBED BY THE SALES CONSULTANT) IN (B)(6) ON (B)(6) 2017, A HARDWARE REMOVAL AND REVISION WAS PERFORMED TO CHANGE THE TREATMENT OPTION IN AN ATTEMPT TO SALVAGE A LIMB. THE SURGEON IN (B)(6)(SURGEON FOR REVISION SURGERY) WAS OF THE OPINION THAT THE PATIENT'S AFFECTED LIMB SHOULD BE AMPUTATED, HOWEVER, THE PATIENT DECIDED THAT SHE WANTED TO KEEP THE LIMB. HENCE, THE SURGEON DECIDED ON ANOTHER TREATMENT OPTION IN AN ATTEMPT TO SALVAGE THE LIMB BY REVISING THE PATIENT TO ANOTHER SET OF HARDWARE. THE SURGEON PROCEEDED WITH REMOVING THE INITIALLY IMPLANTED HARDWARE WHICH INCLUDED ONE (1) INTACT MULTILOC HUMERAL NAIL, TWO INTACT (2) 4.0 MM LOCKING SCREWS AND TWO INTACT (2) 4.5 MM LOCKING SCREWS, WHICH WERE REMOVED UNEVENTFULLY. THERE WAS NO REPORTED SURGICAL DELAY, ADDITIONAL MEDICAL INTERVENTIONS OR ADDITIONAL X-RAYS REQUIRED. THE PATIENT WAS REVISED TO A COMPETITOR¿S ILIZAROV FRAME, WHICH IS AN EXTERNAL FIXATION DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATI

  Patient problems: No Code Available

  MAUDE report 7110256 ↗