BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/70MM

    MDR report key: 3198699 · Received July 1, 2013

    Report

    Report Number
    3003506883-2013-00288
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: JDO. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF OSTEOPOROSIS UNDERWENT INITIAL HIP SURGERY ON (B)(6) 2013. DURING A POST-OP FOLLOW UP EXAM ON (B)(6) 2013, AN X-RAY REVEALED IMPLANT FAILURE OF THE LAG SCREW. ALL IMPLANTS WERE REMOVED DURING REVISION SURGERY ON (B)(6) 2013. THE LAG SCREW, PLATE AND CORTEX SCREW WERE ALL INTACT. THE COMPRESSION SCREW WAS BROKEN IN TWO PIECES WITH THE TIP FOUND STILL INSIDE THE LAG SCREW. BOTH PIECES WERE RETRIEVED. THE PATIENT WAS CONVERTED TO A TOTAL HIP. THIS REPORT IS 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299957 DHS®/DCS® LAG SCREW 12.7MM THREAD/70MM KTT SYNTHES ELMIRA 4687969

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention