BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM TI CORTEX SCREW SELF-TAPPING 10MM

    MDR report key: 3221037 · Received July 11, 2013

    Report

    Report Number
    2520274-2013-04209
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ONLY A FRAGMENT OF THE DEVICE WAS LEFT IN THE PATIENT, SO AN IMPLANT DATE WILL NOT BE PROVIDED. 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

    THE HEADS OF TWO HAND SCREWS BROKE OFF DURING A PROCEDURE ON (B)(6) 2013. SURGEON BURRED THE SHAFT DOWN. THE SURGERY WAS DELAYED 10 MINUTES AS A RESULT OF THIS EVENT. SURGEON COMPLETED THE PROCEDURE. NO EXPLANT IS SCHEDULED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319504 1.3MM TI CORTEX SCREW SELF-TAPPING 10MM MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR