AXSOS 627488Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327082210), received between Oct 18, 2018 and Dec 22, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: PI LINKED TO PI 2869190, THIS PI IS ABOUT THE REVISION SURGERY. "FUSION OF THE PLATE AND SCREWS INSTALLED TWO MONTHS AGO. THEREFORE, PROBLEM WITH REMOVAL DURING REVISION SURGERY. LONGER OPERATION TIME AND INCREASED ANAESTHESIA TIME".

  Patient problems: Insufficient Information

  MAUDE report 13066760 ↗
• MalfunctionDec 13, 2021Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "FUSION OF THE PLATE AND SCREWS INSTALLED TWO MONTHS AGO. THEREFORE, PROBLEM WITH REMOVAL DURING REVISION SURGERY. LONGER OPERATION TIME AND INCREASED ANESTHESIA TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982647 ↗
• InjuryOct 18, 2018Fracture; Fracture; Insufficient Device Problem Information

  THE FOLLOWING EVENT WAS REPORTED BY THE HOSPITAL: "THE RADIOGRAPHIC CONTROL AT 3 MONTHS OF OSTEOSYNTHESIS BY PLATE AND SCREW, SHOWS A RUPTURE OF THE RIGHT DISTAL TIBIA ANTEROLATERAL OSTEOSYNTHESIS PLATE WITH DISTORTION IN FLEXION OF THE TIBIA. THE PATIENT SAID THAT SHE FELT PAIN IN HER LEG AFTER A FEW DAYS OF PARTIAL RECOVERY. IMPOSSIBILITY OF BONE CONSOLIDATION. NEED FOR SURGICAL REVISION. ABLATION OF OSTEOSYNTHESIS EQUIPMENT. BONE SAMPLES TO DETECT AN INFECTION. AT A DISTANCE OF A FEW WEEKS, POSSIBLY CONSIDER A SECOND OSTEOSYNTHESIS BY INTRAMEDULLARY NAILING. THE DEVICE HAS BEEN PRESERVED FOR EXPERTISE. NO MINIMUM SUPPORT 45 DAYS. GENTLE MOBILIZATION OF THE ANKLE FROM DAY + 21 (AFTER SURGICAL CONSULTATION), PARTIAL SUPPORT AT DAY 45."

  Patient problems: Pain; Rupture; Unspecified Infection

  MAUDE report 7982081 ↗