BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 12616340 · Received October 12, 2021

    Report

    Report Number
    1526439-2021-02143
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 14, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN SCREW AND ROD CONSTRUCT ACCESSORY/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, WHILE SCREWING IN A VIPER INNIE WITH THE TORQUE SCREWDRIVER, THE SCREW EXTENSION POPPED OFF; THE INNIE CAME OUT OF THE SITUS AGAIN AT THE TORQUE SHAFT. A THREAD FLANK OF THE INNIE HAD SHEARED OFF. WHILE FEELING FOR THE SCREW HEAD IN SITU, THE SURGEON INJURED THEMSELVES ON THE SHEARED METAL CHIP. ALL FRAGMENTS WERE REMOVED. THE PROCEDURE WAS CHANGED TO A PARTIALLY OPEN PROCEDURE TO LOCK THE CONSTRUCT. THERE WAS A DELAY OF THIRTY MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORY. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510133 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 MIS SINGLE INNER SETSCW| UNK - SCREWS: VIPER PRIME| UNKNOWN SCREWDRIVERS