BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM

    MDR report key: 5128305 · Received October 5, 2015

    Report

    Report Number
    2520274-2015-16422
    Event Type
    Injury
    Date Received
    October 5, 2015
    Report Date
    September 23, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    PMA / PMN Number
    PK142838
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: NKG. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED (B)(4). (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES EU REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON REMOVED ALL IMPLANTS IN A TUMOR PATIENT DUE TO INFECTION RISK AND REPLACED THEM WITH NEW. WHEN TAKING OUT THE OLD IMPLANTS THE SURGEON DISCOVERED THAT ONE OF THE SCREWS IN C2 WAS BROKEN WHERE THE HEAD MEETS THE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658890 3.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM APPLIANCE,FIXATION,SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention