BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM - CURVED ROD

    MDR report key: 7942897 · Received October 8, 2018

    Report

    Report Number
    9615128-2018-00008
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    July 1, 2018
    Report Date
    October 8, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    PMA / PMN Number
    K173487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS INFORMED THAT THE CURVED ROD BROKE A YEAR AFTER IMPLANTATION. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE MORE DATA REGARDING THE EVENT. THE REASON FOR THE BREAKAGE OF THE INVOLVED DEVICE IS UNKNOWN SINCE INFORMATION REGARDING THE INVOLVED DEVICE, THE CASE AND PATIENT, AS WELL AS THE CASE X-RAYS, WERE NOT AVAILABLE. IT IS NOTED, THAT BREAKAGE OF RODS IS KNOWN AND DOCUMENTED IN THE LITERATURE [1] ESPECIALLY IN ONCOLOGY PATIENTS IN WHICH FUSION IS NOT PERFORMED. CARBOFIX INTENDS TO CONTINUE INVESTIGATING THIS CASE BY TRYING TO RETRIEVE MORE INFORMATION DIRECTLY FROM THE SURGEON. LUMBAR TRANSPEDICULAR IMPLANT FAILURE: A CLINICAL AND SURGICAL CHALLENGE AND ITS RADIOLOGICAL ASSESSMENT ASIAN SPINE J. 2014 JUN; 8(3): 281-297.

    Description of Event or Problem · 1

    A YEAR AFTER IMPLANTATION IN AN ONCOLOGICAL PATIENT IN (B)(6), THE CURVED RODS BROKE AND WERE REPLACED IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786014 CARBOCLEAR PEDICLE SCREW SYSTEM - CURVED ROD SPINAL LONGITUDINAL ROD NKB CARBOFIX ORTHOPEDICS LTD. TYPE 2 ROD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention