BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANC EXPANSIONHEAD SCREW SELF-DRILLING 14MM

    MDR report key: 3062995 · Received April 17, 2013

    Report

    Report Number
    2520274-2013-02007
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES CONSULTANT: A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 OF AN ANTERIOR CERVICAL DECOMPRESSION FUSION (ACDF, L6-L7), DUE TO ADJACENT LEVEL DEGENERATIVE DISEASE WITH PATIENT. DURING RE-INSTRUMENTATION AT L5-L6, THE SURGEON PLACED A 4.0MM TI CANCELLOUS EXPANSIONHEAD SCREW SELF DRILLING 14MM LENGTH (HEREAFTER SELF DRILLING SCREW), AND CONNECTED IT WITH A 1.8MM TI LOCKING SCREW (HEREAFTER LOCKING SCREW), IT DID NOT CONNECT. ANOTHER LOCKING SCREW WAS USED WITH THE SAME RESULTS. WHEN THE SURGEON REPLACED THE SELF DRILLING SCREW WITH ANOTHER ONE, THE LOCKING SCREW CONNECTED WITHOUT ANY ISSUES. IT WAS REPORTED THE SURGERY WAS PROLONGED BY NO LONGER THAN THIRTY SECONDS AND THERE WAS NO ADVERSE EVENT TO PATIENT. IT WAS ALSO REPORTED THAT ALL PARTS FROM THE INITIAL ACDF IMPLANT WERE ALL SYNTHES IMPLANTABLE DEVICES. THIS REPORT IS FOR A 4.0MM TI CANCELLOUS EXPANSIONHEAD SCREW SELF DRILLING 14MM LENGTH. THIS IS 5 OF 9 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165038 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-DRILLING 14MM KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention