BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOPEDIATRICS RESPONSE POLYAXIAL PREDICLE SCREW

    MDR report key: 7156314 · Received December 30, 2017

    Report

    Report Number
    3006460162-2017-00033
    Event Type
    Injury
    Date Received
    December 30, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 30, 2017
    Manufacturer
    ORTHOPEDIATRICS, CORP
    Product Code
    NKB
    PMA / PMN Number
    K150600
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SPINAL CURVATURE CORRECTION PROCEDURE, IT WAS DISCOVERED VIA X-RAY THAT THE POLY AXIAL SCREWS ON THE RIGHT AND LEFT SIDE OF THE L2 VERTABRAE FRACTURED MID-SHAFT. UPON REMOVAL OF THE SCREWS, IT WAS FOUND THAT THE SET SCREWS WERE ALSO LOOSE. THE FRACTURED SCREWS WERE REMOVED WITH THE THREADED PORTIONS REMAINING IN BONE. THE CONSTRUCT REMAINS IN PLACE. NO ADDITIONAL INFORMATION ON THIS REPORTED EVENT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935272 UNKNOWN ORTHOPEDIATRICS RESPONSE POLYAXIAL PREDICLE SCREW RESPONSE PEDICLE SCREW SYSTEM NKB ORTHOPEDIATRICS, CORP N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention