BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9M

    MDR report key: 2823588 · Received October 9, 2012

    Report

    Report Number
    8030965-2012-01003
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Report Date
    September 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE CONICAL EXTRACTION SCREW IS BLOCKED, JAMMED IN THE LOCKING CAP RECESS; IT IS INTACT AND NOT BROKEN AS STATED IN COMPLAINT DESCRIPTION. AS THE DEVICE IS BLOCKED, RELEVANT DIMENSIONS CAN NOT BE CHECKED ANYMORE. THE DHR REVIEW FOUND THAT THE DEVICE MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING, DISTRIBUTING.

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. DEVICE IS INCARCERATED IN IMPLANT AND APPEARS TO BE INTACT AND NOT BROKEN AS STATED IN COMPLAINT DESCRIPTION. FROM THE COMPLAINT DESCRIPTION I DO NOT SEE THAT THERE WAS AN ISSUE WITH THE SUBJECT DEVICE. THE DEVICE DOES NOT APPEAR TO BE BROKEN AND HAS PERFORMED AS DESIGNED. AS FOR THE RISK ASSESSMENT, THERE IS NOTHING TO REVIEW SINCE THE DEVICE DID NOT FAIL. THE DEVICE FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED, ON AN UNK DATE, WITH CLICK'X' CONSTRUCT LEVEL L3-S1. PT WAS DISCOVERED TO HAVE STENOSIS AND A HERNIATED DISC AT L2-L3. PT WAS RETURNED TO HE OPERATING ROOM ON (B)(6) 2012 FOR HARDWARE REMOVAL, AND REVISION TO EXTEND CONSTRUCT TO L2-L3, PLACING A VERTEBRAL SPACER AT L2-L3, AND IMPLANTING NEW HARDWARE FROM L3-S1. WHILE REMOVING THE HARDWARE, THE EXTRACTION SCREW BROKE OFF INSIDE ONE OF THE LOCKING CAPS AND AT L5 LEFT, THE SCREW HEAD CAME OFF UPON REMOVAL. ALL HARDWARE WAS REMOVED WITH THE EXCEPTION OF TWO SCREWS AT L4 REMAIN IMPLANTED. THIS IS 17 OF 17 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9M EXTRACTION SCREW HWC SYNTHES GMBH 2589015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR SCREW| ROD| LOCKING CAP