BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPONSE 5.5-6.0 UNIAXIAL PEDICLE SCREW 5.0MM X 35MM

    MDR report key: 10607762 · Received September 30, 2020

    Report

    Report Number
    3006460162-2020-00105
    Event Type
    Injury
    Date Received
    September 30, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 30, 2020
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    PMA / PMN Number
    K193100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION, BECAUSE THE DEVICE IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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 APPROX. IMPLANT DATE WAS (B)(6) 2019, FIRST BROKEN SCREW FOUND AT 6 MO POST OP VISIT THEN A 2ND SCREW FOUND AT 13 MO POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075102 RESPONSE 5.5-6.0 UNIAXIAL PEDICLE SCREW 5.0MM X 35MM PEDICLE SCREW NKB ORTHOPEDIATRICS, CORP 00-1300-0535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other