BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5-6.0 UNIAXIAL PEDICLE SCREW 5.5 X 45MM

    MDR report key: 10384509 · Received August 10, 2020

    Report

    Report Number
    3006460162-2020-00090
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    PMA / PMN Number
    K193100
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN. THE ORIGINAL CONSTRUCT WAS A T11 TO L3 FUSION. THE 6.5X45MM UNIAXIAL SCREWS APPEARED BROKEN ON THE X-RAY. IT WAS DETERMINED ADEQUATE FUSION BETWEEN L2-L3 WAS NOT ACHIEVED. BROKEN SCREWS WERE REMOVED AND REPLACED WITH 7.0 X 45MM UNIAXIAL SCREWS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848506 5.5-6.0 UNIAXIAL PEDICLE SCREW 5.5 X 45MM RESPONSE PEDICLE SCREW NKB ORTHOPEDIATRICS, CORP 00-1300-6545 M71735-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention