BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING CANNULATED BLADE PLATE

    MDR report key: 3905039 · Received May 27, 2014

    Report

    Report Number
    3006460162-2014-00008
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ORTHOPEDIATRICS CORP.
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL RISK ASSESSMENT (HHE) DETERMINED THAT THIS MALFUNCTION DID NOT MEET THE REQUIREMENTS OF A MANDATORY REPORTABLE ADVERSE EVENT PER 21CFR803.50 BUT THE FIRM WISHES TO REPORT THE MALFUNCTION.

    Description of Event or Problem · 1

    X-RAY REVEALED A BROKEN PLATE AT 3 WEEK FOLLOW UP. PLATE WAS BROKEN THROUGH MOST PROXIMAL SCREW HOLE. SURGEON STATED THERE WAS EVIDENCE OF CALLUS FORMATION AND NO EVIDENCE OF LOSS OF CORRECTION, SO NO REVISION SURGERY IS PLANNED AT THIS TIME. MORE RECENT FOLLOW UP X-RAY INDICATED CONTINUED BONE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312007 LOCKING CANNULATED BLADE PLATE BONE PLATE HRS ORTHOPEDIATRICS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR