BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 16570099 · Received March 18, 2023

    Report

    Report Number
    2027754-2023-00006
    Event Type
    Injury
    Date Received
    March 18, 2023
    Report Date
    April 4, 2023
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS CURRENTLY PENDING, AND A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2023-00007 WHICH IS FOR THE OTHER PATIENT DESCRIBED IN THIS ARTICLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DOCUMENTED AS A RESULT OF REVIEW OF SCIENTIFIC LITERATURE ARTICLE DUE TO THE PATIENT OUTCOMES OF STIFFNESS AND WOUND BREAKDOWN REPORTED. DEVICE INFORMATION (MODEL NUMBER AND BATCH/LOT NUMBER) IS UNKNOWN. THEREFORE, DHR REVIEW AND INVENTORY REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. ADDITIONALLY, AS THE DEVICE INFORMATION IS UNKNOWN, A REVIEW OF THE NCR, CAPA, AND COMPLAINT DATABASE COULD NOT BE PERFORMED BASED ON PART NUMBER; HOWEVER, A REVIEW WAS STILL PERFORMED BASED ON THE REPORTED PATIENT OUTCOMES. THE REVIEW OF THE COMPLAINT DATABASE ONLY RESULTED IN THE COMPLAINT WITHIN THIS REPORT AND COMPLAINT IN RELATED REPORT (2027754-2023-00007) DOCUMENTED FOR THE SECOND PATIENT MENTIONED IN THIS ARTICLE. AS THE REPORTED EVENT DESCRIBED POST-OP PATIENT COMPLICATIONS OF STIFFNESS AND WOUND BREAKDOWN, THESE ISSUES COULD BE RELATED TO THE DEVICE OR COULD BE ADVERSE EVENTS WITHOUT ANY IDENTIFIED DEVICE OR USE PROBLEM. HOWEVER, AS THE DEVICES COULD NOT BE EVALUATED, THIS COULD NOT BE DETERMINED. THEREFORE, BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IN THE ARTICLE "MINIMALLY INVASIVE PLATING OF DISTAL RADIUS FRACTURE: A SERIES OF 42 CASES AND REVIEW OF CURRENT LITERATURE" BY SATRIA O, ET AL, AN "EXTREMILOCK¿ WRIST SHORT NARROW PLATE" WAS USED IN THIS SERIES. THIS STUDY INCLUDED 42 PATIENTS WITH DISTAL RADIUS FRACTURES WHO UNDERWENT MINIMALLY INVASIVE SURGERY, OF WHICH 24 WERE MALE (57.1%) AND 18 WERE FEMALE (42.9%) WITH A MEAN AGE OF 41.14 YEARS (RANGE 21-65). IN THE ARTICLE IT WAS STATED "ALL PATIENTS UNDERWENT A MINIMALLY INVASIVE APPROACH USING CLOSED REDUCTION AND PLATE AND SCREW FIXATION. ARTHROSCOPY WAS PERFORMED IN SIX PATIENTS WITH INTRAARTICULAR INVOLVEMENT. TWO PATIENTS REPORTED EARLY COMPLICATIONS, SUCH AS STIFFNESS AND WOUND BREAKDOWN. HOWEVER, THE COMPLICATIONS RESOLVED ON THEIR OWN." THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939305 PLATE, FIXATION, BONE HRS OSTEOMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other