NA 1896-5080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540202574), received between Oct 1, 2015 and May 26, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 18, 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.

• InjuryMay 26, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE DOCTOR PUT A NAIL IN TO HELP A BROKEN TIBIA AND 8-10 DAYS LATER PATIENT WENT IN AND HAD THE STAPLES TAKEN OUT AND WAS BANDAGED UP. A FEW HOURS (3-4) AFTER RETURNING HOME THE PATIENT NOTICED BLOOD AROUND THE BANDAGED AREA AND THE SCREW BACKING OUT. PATIENT CALLED THE DOCTOR AND WAS ADVISED TO GO THE ER. SCREW WAS REMOVED WHEN PATIENT WENT TO THE ER. SCREW PROTRUDING FROM LEFT SIDE ANKLE. ED RECOMMENDED WEARING A NON-WEIGHT BEARING BOOT. PT WAS PROVIDED A PRESCRIPTION FOR ANTIBIOTICS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17010922 ↗
• InjuryAug 10, 2018Device Dislodged or Dislocated

  THE SURGEON REPORTED THAT THE PATIENT HAD UNDERGONE A T2 RECON NAIL PROCEDURE ON (B)(6) 2017 AND AFTER THE PROCEDURE IT WAS NOTICED THAT THE T2 5MM LOCKING SCREW HAD BACKED OUT.

  Patient problems: No Code Available

  MAUDE report 7773464 ↗
• InjuryMay 29, 2018Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT PATIENT'S RIGHT TIBIA WAS REVISED AFTER PATIENT WALKED ON THE ROD AND DISPLACED IT. REP REPORTED THAT HE HAS NO ACCESS TO ANY ADDITIONAL INFORMATION DUE TO NOT BEING ALLOWED ACCESS TO THE HOSPITAL'S PASSWORD-PROTECTED SYSTEMS. REP REPORTED THAT THE NAIL AND 5 SCREWS (3 PROXIMAL, 2 DISTAL) WERE EXPLANTED. HOSPITAL IMPLANT SHEET SHOWS A NAIL AND 6 SCREWS. ADDITIONAL INFO RECEIVED FROM REP'S EMAIL: THERE WAS A SCREW EXCHANGE FROM THE PRIMARY SURGERY DUE TO LENGTH. ONLY 5 SCREWS WERE IMPLANTED. IN INITIAL SURGERY, A 6TH SCREW WAS USED BUT IMMEDIATELY TAKEN OUT. HE DOES NOT KNOW WHICH SCREWS WERE USED AND WHICH ONE WAS NOT USED. THE DISTAL TIBIA DISPLACED NOT THE TIBIAL ROD. ADDITIONAL INFO RECEIVED FROM PHONE CALL WITH REP: REVISION NEEDED BECAUSE "PATIENT WALKED ON LEG WHEN SHOULDN'T HAVE" AND THE BONE MOVED. SURGEON FELT THAT PLATES GAVE A BETTER REDUCTION SO HE SWITCHED FROM THE NAILING SYSTEM TO PLATING.

  Patient problems: No Code Available

  MAUDE report 7551197 ↗
• InjuryOct 1, 2015Loss of or Failure to Bond

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 5116379 ↗