CHS 71123134Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010174772), received between Aug 29, 2024 and Aug 29, 2024 — 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROPHYLACTIC INTERNAL FIXATION OF THE RIGHT HIP IN (B)(6) 2019 DUE TO A BONE ISSUE WHICH WAS A RIGHT PROXIMAL NON OSSIFYING FIBROMA OF THE FEMUR. AFTER THE PROCEDURE, THE PATIENT HAD A RIGHT PROXIMAL FEMORAL SHAFT PERIPROSTHETIC FRACTURE. THIS ISSUE WAS ADDRESSED ON (B)(6) 2022 WITH AN OPEN REDUCTION AND INTERNAL FIXATION OF THE RIGHT FEMORAL SHAFT FRACTURE UTILIZING AN INTRAMEDULLARY NAIL. AFTER PLACEMENT OF THE NAIL, IT WAS NOTED THAT THERE WAS A SMALL FRACTURE THAT PROPAGATED FROM THE PRIMARY FRACTURE ALONG THE POSTERIOR RIDGE OF THE PRIOR HARDWARE. THE FRACTURE EXTENDED PROXIMALLY TO THE LAG SCREWS BUT DID NOT EXTEND PROXIMAL TO THE SCREWS. THE REDUCTION AND THE CONSTRUCT REMAIN STABLE. THE PATIENT HAD A SATISFACTORY RESULT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 20103008 ↗