BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM (CUSTOM-MADE RODS)

    MDR report key: 14521542 · Received May 27, 2022

    Report

    Report Number
    9615128-2022-00002
    Event Type
    Death
    Date Received
    May 27, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 26, 2022
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE VBR SUBSIDENCE IN AN ONCOLOGIC PATIENT, AN UNREASONABLE STRESS WAS APPLIED ON THE RODS, WHICH MOST PROBABLY LED TO THEIR BREAKAGE AND SUBSEQUENTLY THE PATIENT REQUIRED A REVISION SURGERY. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICES DID NOT REVEAL DEVIATION FROM SPECIFICATION. IT IS NOTED, THAT DURING OPERATION, THE INVOLVED RODS WERE SLIGHTLY CUT TO ADJUST THEIR LENGTH TO THE ONE REQUIRED, AND THE PORTIONS WHICH WERE NOT IMPLANTED WERE SENT TO THE MANUFACTURER FOR EXAMINATION. THOSE RODS' SEGMENTS WERE TESTED FOR FOUR-POINT BENDING AND UNDERWENT DIMENSIONAL EXAMINATION, AND THE RESULTS COMPLY WITH THE DEVICE SPECIFICATION. IMPORTANTLY, BASED ON INFORMATION PROVIDED TO THE COMPANY BY THE (B)(6) DISTRIBUTOR, THE PATIENT DIED TOWARDS THE END OF THE SURGICAL PROCEDURE, AFTER THE CARBOFIX CONSTRUCTION WAS REMOVED AND METAL CONSTRUCTION WAS IMPLANTED. THEREFORE, IT IS CONCLUDED THAT THE VASCULAR DAMAGE AND DEATH OF THE PATIENT WAS RELATED TO THE SURGICAL PROCEDURE AND, MOST PROBABLY, ALSO TO THE ONCOLOGICAL CONDITION OF THE PATIENT, AND NOT RELATED TO CARBOFIX DEVICE.

    Description of Event or Problem · 0

    A (B)(6) PATIENT SUFFERING FROM CHONDROSARCOMA WAS OPERATED IN THE (B)(6) , UNDERGOING T6 TO T9 VERTEBRECTOMY AND IMPLANTATION OF CARBOFIX PEDICLE SCREW SYSTEM WITH CUSTOM-MADE CFRP RODS AND VBR. DUE TO SUBSIDENCE OF THE VBR DEVICE, THE PATIENT HAS BEEN REVISED TWO MONTHS LATER ((B)(6) 2021), REPLACING THE VBR AND THE RODS (WHILE INCREASING VERTEBRECTOMY TO T5 TO T10). THE VBR IMPLANTED ON (B)(6) 2021 HAS SUBSIDED, CAUSING, MOST PROBABLY, THE RODS TO BREAK. ON A SECOND REVISION SURGERY CONDUCTED ON (B)(6) 2022, THE CARBOFIX CONSTRUCT WAS REMOVED AND REPLACED WITH A METAL CONSTRUCT. TOWARDS THE END OF THE SURGICAL PROCEDURE, THE PATIENT'S AORTA WAS SEVERED AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711029 CARBOCLEAR PEDICLE SCREW SYSTEM (CUSTOM-MADE RODS) PEDICLE SCREW SYSTEM (ROD) NKB CARBOFIX ORTHOPEDICS LTD. CUSTOM-MADE ROD 92377

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death