BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 28MM

    MDR report key: 3093493 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02290
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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: PATIENT FELL ON LEFT ELBOW ON (B)(6) 2012. PATIENT WAS TAKEN TO OR AND IMPLANTED WITH PLATE AND SCREWS ON (B)(6) 2012. POST OP X-RAYS LOOKED GREAT BUT AFTER A FEW WEEKS, THE IMPLANT FAILED. AFTER SPEAKING WITH THE SURGEON, HE DID NOT KNOW IF IT WAS BECAUSE OF THE OSTEOPOROTIC BONE, OR IF THE 2.7MM SCREWS WERE SIMPLY TOO BIG. HE DID NOT FILL ALL SCREW HOLES. AT THIS TIME THE PLATE HAS NOT BEEN REMOVED. THIS REPORT IS FOR A 3.5MM CORTEX SCREW SELF-TAPPING 28MM. THIS IS 7 OF 9 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197312 3.5MM CORTEX SCREW SELF-TAPPING 28MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR