EXPert Nail 04.008.266SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982087263), received between Oct 24, 2018 and Dec 8, 2020 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K051678); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE HINDFOOT NAIL FOLLOWED BY IMPLANTATION OF THE MAX-FRAME SYSTEM DUE TO AN INFECTED NONUNION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A HINDFOOT ARTHRODESIS NAILING SYSTEM ON (B)(6) 2020. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10969380 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS (B)(6) 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002304 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051678. One submission often covers many models, so check the product and lot details in each record.

• Z-1234-2024 · Jan 24, 2024 · Open, Classified
  13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability