VALOR 4151150075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840420115843), received between Nov 10, 2021 and Feb 14, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING LOWER LEG AND ANKLE. IT WAS ALSO NOTED THAT THE IM NAIL LOOSENED AND CAUSED INFECTION THAT LED TO A NONUNION OF THE ANKLE FUSION SITE. IT REQUIRED REMOVAL OF THE IM NAIL WITH BONE BIOPSIES AND PLACEMENT OF ABX CEMENT NAIL. IN ADDITION TO THAT THE PATIENT WAS GIVEN IV ANTIBIOTICS FOR 6 WEEKS FOLLOWED WITH REVISION OF ANKLE FUSION WITH EXTERNAL FIXATOR.

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13524936 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IM NAIL LOOSENED AND CAUSED INFECTION THAT LED TO A NONUNION OF THE ANKLE FUSION SITE. IT REQUIRED REMOVAL OF THE IM NAIL WITH BONE BIOPSIES AND PLACEMENT OF ANTIBIOTIC CEMENT NAIL WITH IV ANTIBIOTICS FOLLOWED BY REVISION OF ANKLE FUSION WITH EXTERNAL FIXATOR.

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13524043 ↗
• InjuryNov 10, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT A TRI-MALLEOLAR FRACTURE WITH A HINDFOOT NAIL. THE POSTERIOR CALCANEUS SCREW WAS REVISED AS IT HAD BACKED OUT OF THE NAIL. THE SAME SCREW WAS RE-INSERTED THROUGH THE NAIL AND AN END CAP WAS USED TO PREVENT THE SCREW FROM BACKING OUT AGAIN. AFTER THE SURGEON INSERTED THE END CAP, HE WANTED TO ADVANCE THE POSTERIOR SCREW A LITTLE FURTHER WHICH HE WAS ABLE TO WITH THE END CAP ON. HE THEN TESTED TO SEE THAT THE END CAP WAS WORKING AND COULD NOT BACK-OUT THE POSTERIOR SCREW WITH THE END CAP ON.

  Patient problems: Failure of Implant

  MAUDE report 12790617 ↗
• MalfunctionNov 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT A TRI-MALLEOLAR FRACTURE WITH A HINDFOOT NAIL. THE POSTERIOR CALCANEUS SCREW WAS REVISED AS IT HAD BACKED OUT OF THE NAIL. THE SAME SCREW WAS RE-INSERTED THROUGH THE NAIL AND AN END CAP WAS USED TO PREVENT THE SCREW FROM BACKING OUT AGAIN. AFTER THE SURGEON INSERTED THE END CAP, HE WANTED TO ADVANCE THE POSTERIOR SCREW A LITTLE FURTHER WHICH HE WAS ABLE TO WITH THE END CAP ON. HE THEN TESTED TO SEE THAT THE END CAP WAS WORKING AND COULD NOT BACK-OUT THE POSTERIOR SCREW WITH THE END CAP ON. 3 MONTHS LATER IT WAS FOUND ON X-RAY THAT THE POSTERIOR CALCANEUS SCREW HAD BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 12789749 ↗