BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE

    MDR report key: 3002414 · Received March 8, 2013

    Report

    Report Number
    3006460162-2013-00006
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ORTHOPEDIATRICS CORP
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LOCKING CANNULATED BLADE PLATE BENT INTRA OPERATIVELY. IN AN EFFORT TO GET THE HIP RELOCATED IN THE ACETABULUM PRIOR TO DOING THE ACETABULAR OSTEOTOMY, THE SURGEON HAD TO ABDUCT THE HIP. IT WAS AFTER DOING THIS MANOEUVER THAT THE SURGEON NOTICED THAT HE HAD BENT THE PLATE. SURGEON REPLACED INITIAL "INFANT-SIZED" PLATE WITH A "CHILD-SIZED" PLATE. THIS REQUIRED EXTENDED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99580 ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE BLADE PLATE HRS ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention