SMART TOE ST0A-19PRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252263432), received between Mar 11, 2019 and Sep 23, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 23, 2024Premature Activation; Premature Activation

  AS REPORTED BY THE REP: "IMPLANTS EXPANDED IMMEDIATELY AFTER TAKING OUT FROM THE PACKAGING SO THE IMPLANT COULD NOT BE INSERTED." THE CUSTOMER CONFIRMED THAT THE IMPLANTS WERE STORED AT 0 DEGREES CELSIUS, OR BELOW, FOR A MINIMUM OF 2 HOURS BEFORE THE PROCEDURE AND WERE ONLY REMOVED FROM COLD STORAGE AT THE TIME OF IMPLANTING, AND NOT PRIOR. THE SURGEON HAD TO SWITCH TO INSERTING A TEMPORARY GUIDEWIRE TO TREAT THE PATIENT¿S HAMMERTOE. THIS WAS DIFFERENT TO WHAT WAS PLANNED BUT WAS THE ONLY WAY TO STABILIZE THE JOINT.

  Patient problems: Insufficient Information

  MAUDE report 20284633 ↗
• MalfunctionAug 26, 2021Activation Failure; Activation Failure

  IT WAS REPORTED: "WHEN PLACING THE SMART TOE 2 IMPLANT DID NOT EXPAND UPON HEATING UP. NON EXPANDING IMPLANT WAS REMOVED AND EXCHANGED FOR DIFFERENT SMART TOE IMPLANT THAT PERFORMED AS EXPECTED. A SURGICAL DELAY OF 45MIN WAS REPORTED."

  Patient problems: Failure of Implant

  MAUDE report 12374426 ↗
• InjuryNov 2, 2020Fracture; Fracture

  AS REPORTED: "PRIMARY SURGERY TOOK PLACE IN (B)(6). THE PATIENT REPORTED UNCHANGED PRE-EXISTING LOAD-DEPENDENT PAIN IN THE LEFT FOREFOOT, WITH THE TOES LL - LV EQUALLY PAINFUL. LEFT FOOT: INTEGUMENT INTACT WITH SCARRING WITHOUT IRRITATION. PAIN PROVOCATION WHEN MANIPULATING THE PRP JOINT DIG. LL - LV. DLP JOINT _DEG DIG. IV IN A SUBLUXATED PLANTAR POSITION. BEGINNING MALLET TOE SHAPE ALSO LL AND LLL, BUT CAN BE REPOSITIONED. SQUEEZE-IEST NEGATIVE. NO MULDER'S CLICK. MODERATE PLANTAR HYPERTENSION MTP V-JOINT. PO-NAS INTACT. X-RAY FOOT TO THE SIDE / OBLIQUE LEFT FROM (B)(6) 2020: NEW LYSIS BORDER AROUND THE DISTAL IMPLANT COMPONENT IN THE MIDDLE PHALANX IV AND FRACTURE OF THE PROXIMAL IMPLANT COMPONENT IN THE PROXIMAL PHALANX IV. THE SMART TOE IMPLANTS IN THE 2ND AND 3RD BEAM INTACT AND WITHOUT SIGNS OF EASING WITH ALSO ADVANCED CONSOLIDATION. WELL KNOWN ST.N. HAMME TOE CORRECTION DIG. LL-LV USING SMART TOE LMPLANTATEN WITH NEW FRACTURE AND LOOSENING OF THE IMPLANT IN DIG. LV AND LACK OF CONSOLIDATION THERE. NO PROGRESSIVE DEGENERATION. NOT A MORTON'S NEUROMA. A NEW CLINICAL AND RADIOLOGICAL RUPTURE OF THE SMART TOE IMPLANT OF THE DIG IS EVIDENT. IV. IN ADDITION, THERE WAS A SLIGHT L

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10771191 ↗
• MalfunctionMar 11, 2019Manufacturing, Packaging or Shipping Problem

  CUSTOMER REPORTED THAT INCORRECT IMPLANTS WERE FOUND IN PACKAGING UPON OPENING THE PRODUCT. THIS IMPLANT WAS NOT FITTED AND A NEW IMPLANT WAS USED WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409347 ↗