BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM (ROD)

    MDR report key: 11744190 · Received April 29, 2021

    Report

    Report Number
    9615128-2021-00002
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 28, 2021
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    UDI-DI
    07290109336367
    PMA / PMN Number
    K173487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ONCOLOGY PATIENT UNDERWENT FIXATION SURGERY FROM T12 TO S2 VERTEBRAE WITH L3 AND PART OF L4 VERTEBRAE REMOVED. A FIBULA BONE AND A CAGE WERE USED FOR ANTERIOR SUPPORT. IMAGING OF THE CASE WERE NOT AVAILABLE TO THE COMPANY AT THE TIME OF THIS REPORT. ACCORDING TO THE (B)(4) DISTRIBUTOR, IMAGING PERFORMED TWO DAYS AFTER THE OPERATION, REVEALED ANGLING OF THE FIBULA STRUT ANTERIORLY AT THE PROXIMAL END AND SUBSIDING OF THE CAGE. FOUR WEEKS POST-OPERATION, DURING PATIENT EXTENSION, THE RODS BROKE. IMAGING PERFORMED AFTER THE RODS' BREAKAGE SHOWED FIBULA STRUT ANGLED POSTERIORLY AT THE ANTERIOR END. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED RODS INDICATED THEY WERE MANUFACTURED ACCORDING TO SPECIFICATION. EXAMINATION OF THE RODS THEMSELVES DID NOT REVEAL ANY DEVIATION FROM SPECIFICATION. IT IS THE COMPANY'S CONCLUSION THAT THE USE OF THE FIBULA BONE AND CAGE AS ANTERIOR SUPPORT AND THE MIGRATION/SUBSIDENCE CAUSED AN UNREASONABLE LOAD ON THE RODS AND AS A RESULT LED TO THEIR BREAKAGE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641437 CARBOCLEAR PEDICLE SCREW SYSTEM (ROD) PEDICLE SCREW SYSTEM (ROD) NKB CARBOFIX ORTHOPEDICS LTD. TYPE 4 ROD 79321 07290109336367

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention| S