NA 1896-5070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540202550), received between Oct 1, 2015 and May 12, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SCREW BROKE OFF DURING EXTRACTION SURGERY. THE EXTRACTION WAS A PLANNED REMOVAL. ALL DEBRIS WAS REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380776 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ALLERGIC REACTION, SKIN REDNESS 10 WEEKS POST SURGERY.

  Patient problems: Irritation; Reaction

  MAUDE report 9522046 ↗
• InjuryMay 29, 2018Appropriate Device Problem Term/Code Not Available

  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 Information

  MAUDE report 7551207 ↗
• 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 7551204 ↗
• 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 5116422 ↗