BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPONSE 5X35 UNIAXIAL PEDICLE SCREW

    MDR report key: 10600161 · Received September 29, 2020

    Report

    Report Number
    3006460162-2020-00102
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 27, 2020
    Report Date
    September 29, 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 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 A POSTERIOR SPINAL FUSION PERFORMED BY DR. (B)(6) ON (B)(6) 2020. MOST PROXIMAL SCREW ON RIGHT SIDE OF CONSTRUCT BROKE IN THE MID-SHAFT IN THE MONTHS FOLLOWING. REMOVED PORTION OF SCREW ON (B)(6) 2020 AND USED A BAND IN IT'S PLACE IN THE REVISION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064575 RESPONSE 5X35 UNIAXIAL PEDICLE SCREW PEDICLE SCREW NKB ORTHOPEDIATRICS, CORP 00-1300-0535 202980-L

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention