BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC NAILING PLATFORM 10MM X 300MM ADOLESCENT NAIL, RIGHT

    MDR report key: 10407456 · Received August 14, 2020

    Report

    Report Number
    3006460162-2020-00093
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 14, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    HSB
    PMA / PMN Number
    K172583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE ((B)(6) KG) WITH KNOWN HISTORY OF PFFD TREATED INITIALLY (DATE UNKNOWN) AT (B)(6) WITH PRECISE NAIL. SHE HAD A REVISION PROCEDURE PERFORMED BY DR. (B)(6) (REMOVAL OF PRECISE AND IMPLANTATION OF PNP) IN (B)(6) 2020. IN (B)(6) 2020, DR. (B)(6) REMOVED HER PROXIMAL INTERLOCK SCREW. SHE PRESENTED WITH PAIN IN CLINIC ON (B)(6). ON (B)(6), WE REMOVED THE BROKEN HARDWARE AND RE-IMPLANTED A NEW 10X 30 CM PNP NAIL. THE NAIL WAS RETRIEVED, AND WE WILL SHIP BACK TO THE MANUFACTURER. THE INITIAL REPORTER INDICATED THAT SHE IS A GYMNAST AND WAS PERFORMING BACK HAND-SPRINGS POST SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875028 PEDIATRIC NAILING PLATFORM 10MM X 300MM ADOLESCENT NAIL, RIGHT INTRAMEDULLARY NAIL HSB ORTHOPEDIATRICS, CORP 00-1504-1030

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention