BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIATRICS BLADE PLATE SYSTEM

    MDR report key: 6910835 · Received October 3, 2017

    Report

    Report Number
    3006460162-2017-00018
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    August 30, 2017
    Report Date
    February 28, 2018
    Manufacturer
    ORTHOPEDIATRICS
    Product Code
    HRS
    PMA / PMN Number
    K110959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS THE PATIENT'S FAMILY HAS RETAINED THE DEVICE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FRACTURED LCB PLATE WAS NOT RETURNED FOR ANALYSIS. ALTHOUGH THE ACTUAL LOT NUMBER IS UNKNOWN, BASED ON THE HISTORY OF DELIVERED PRODUCT, WE HAVE DETERMINED THAT THE FOLLOWING LOT NUMBERS SHOULD BE CONSIDERED. LOT: 141556-A, 141691-A, 150524-A, 152003-A, 160714-A, 160942-A, AND 160961-J. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IT CAN BE CONSIDERED BASED ON MEDICAL ASSESSMENT OF X-RAYS AND INITIAL PATIENT DIAGNOSIS, THAT THE UTILIZED PLATE SIZE COULD HAVE CONTRIBUTED TO THE EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A FOLLOW-UP WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A VALGISATION OSTEOTOMY PROCEDURE, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURE OF THE BLADE PLATE AT THE MOST PROXIMAL HOLE OF THE PLATE SHAFT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690745 ORTHOPEDIATRICS BLADE PLATE SYSTEM 130 DEGREE LOCKING CANNULATED INFANT BLADE 35MM X 0MM X 3 HOLE HRS ORTHOPEDIATRICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R