BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING CANNULATED BLADE PLATE

    MDR report key: 4324812 · Received December 5, 2014

    Report

    Report Number
    3006460162-2014-00012
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 9, 2014
    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

    Additional Manufacturer Narrative · 1

    EVIDENCE OF A DELAYED UNION WAS OBSERVED AT TIME OF REVISION SURGERY. SURGEON ALSO SUGGESTED THAT HE MAY HAVE UTILIZED TOO SMALL OF A PLATE FOR THE PT AND REPORTED THAT IN RETROSPECT HE WISHED HE HAD UTILIZED THE LOCKING PROXIMAL SCREW FEATURE OF THE DEVICE TO HELP STABILIZE THE OSTEOTOMY BECAUSE HE FELT THAT THERE WAS EVIDENCE OF MICRO MOTION AT THE OSTEOTOMY SITE. THE MAL UNION AND MICRO MOTION PROBABLE RESULTED IN A FATIGUE FAILURE OF THE DEVICE. REVISION SURGERY UTILIZED THE LARGER SIZE OF SAME DEVICE WITH POSITIVE OUTCOME.

    Description of Event or Problem · 1

    PLATE FRACTURED THROUGH SCREW HOLE IN INFANT BLADE PLATE: BI LATERAL INFANT BLADE PLATES IMPLANTED ON (B)(6) 2014. BROKEN BLADE PLATE WAS REMOVED FROM LEFT PROXIMAL FEMUR. PLATE BROKE AT MOST PROXIMAL SHAFT HOLE (COMPRESSION HOLE). PT WAS IN SPICA 4 WEEKS, ROM EXERCISE AND THEN COULD WEIGHT BEAR 4 WEEKS LATER. PT PRESENTED 4/25 WITH PAIN IN LEFT HIP. NO TRAUMA OR FALL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786556 LOCKING CANNULATED BLADE PLATE BLADE PLATE HRS ORTHOPEDIATRICS CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR