BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS BLADE PLATE

    MDR report key: 7033540 · Received November 15, 2017

    Report

    Report Number
    3006460162-2017-00027
    Event Type
    Injury
    Date Received
    November 15, 2017
    Report Date
    April 17, 2018
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT DEVICE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE PLATE FRACTURED AT THE PROXIMAL COMPRESSION HOLE AT THE SCALLOP. THERE ALSO APPEARED TO BE STRESS CRACKS ON THE UNDERSIDE OF THE SCALLOP. THE DEVICE HISTORY RECORD WAS REVIEWED AND IT WAS FOUND THAT THE PARTS WERE MADE TO SPECIFICATION WITH NO REWORK OR DEVIATIONS. THE PLATE FRACTURED IN THE AREA IT WAS MOST LIKELY TO BASED ON THE FINITE ELEMENT ANALYSIS CONDUCTED. PER ORTHOPEDIATRICS, CORP (B)(4), A RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS "BENDING, FRACTURE, OR MIGRATION OF THE IMPLANT". IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING THE IMPLANTATION OF THE LOCKING CANNULATED BLADE PLATE, THE PATIENT WAS REVISED DUE TO PLATE FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814331 ORTHOPEDIATRICS BLADE PLATE 130 DEGREE LOCKING CANNULATED ADOLESCENT BLADE PLATE HRS ORTHOPEDIATRICS N/A 164395-B

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention