BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW

    MDR report key: 17411920 · Received July 28, 2023

    Report

    Report Number
    3006493760-2023-00002
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 28, 2023
    Manufacturer
    ICOTEC AG
    Product Code
    MQP
    UDI-DI
    07640164847849
    PMA / PMN Number
    K200235
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION DOCUMENTATION OF THE SCREWDRIVER HAS BEEN CHECKED, NO ANOMALIES WERE DETECTED WHEN THE SCREWDRIVER WAS RELEASED TO THE MARKET. MICROSTRUCTURE AND HARDNESS OF THE DEVICE MATERIAL HAVE BEEN EVALUATED. NO ABNORMALITIES WERE DETECTED. MATERIAL PROPERTIES WERE WITHIN SPECIFICATIONS. TORQUE MEASUREMENT TESTS ON PROTOTYPES MADE OF IDENTICAL MATERIAL HAVE BEEN DONE AND HAVE LED TO THE CONCLUSION THAT THE SPECIFIED TORQUE WAS ACHIEVED. AN ADDITIONAL FEA (FINITE ELEMENT ANALYSIS) HAS BEEN CARRIED OUT AND HAS SHOWN FRACTURES ONLY WELL ABOVE THE SPECIFIED 1 NM. THIS CONFIRMS THE SAFE USE OF THE INSTRUMENT DURING THE INTENDED USE (USE WITH TORQUE LIMITING HANDLE). BASED ON THE RESULTS OF THE INVESTIGATIONS AND THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE DEFINITE ROOT CAUSE FOR THE INCIDENT. BASED ON THE INFORMATION RECEIVED, OVER-TORSION CAN NOT BE EXCLUDED AS THE INTENDED HANDLE (WITH TORQUE LIMITATION) MAY NOT HAVE BEEN USED IN THE SURGERY.

    Description of Event or Problem · 0

    DURING A CORPECTOMY PROCEDURE AN EXPANDABLE ICOTEC VBR IMPLANT WAS IMPLANTED. FOLLOWING EXPANSION OF THE IMPLANT THE HEIGHT OF THE VBR WAS FIXED WITH THE LOCKING SCREW. THE SCREWDRIVER INTENDED FOR LOCKING MUST BE USED TOGETHER WITH THE RESPECTIVE TORQUE LIMITING HANDLE (1 NM). AFTER CHECKING THE IMPLANT POSITION THE SURGEON DECIDED TO READJUST THE POSITION OF THE VBR. WHEN TRYING TO LOOSEN THE SET SCREW, THE SURGEON NOTICED THAT THE SCREWDRIVER TIP HAD SHEARED OFF. THE SITUS WAS INSPECTED WITH IMAGING TOOLS BUT THE FRAGMENT WAS NOT FOUND. IT IS THEREFORE ASSUMED THAT THE FRAGMENT DID NOT REMAIN IN THE PATIENT. IT WAS NOT POSSIBLE TO READJUST THE POSITION OF THE VBR. THE SURGEON DECIDED TO LEAVE THE IMPLANT AS IT WAS AND TO COMPLETE THE SURGERY. DUE TO THE RESULT OF A FOLLOW-UP EXAMINATION (SUBOPTIMAL PLACEMENT OF THE VBR), THE SURGEON DECIDED TO REVISE THE IMPLANT. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814616 KONG-TL VBR SYSTEM, SCREWDRIVER FOR LOCKING SCREW Spinal vertebral body replacement device MQP ICOTEC AG 44-050 20/02 07640164847849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention