BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 22MM

    MDR report key: 3187320 · Received June 25, 2013

    Report

    Report Number
    2520274-2013-03771
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH 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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS THE 510K #: K102694.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH PLATE AND SCREWS ON (B)(6) 2012. PATIENT COMPLAINED OF PAIN FROM IMPLANT ON (B)(6) 2013. THE PLATE AND SCREWS WERE PLANNED FOR REMOVAL ON (B)(6) 2013. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289440 2.4MM VA LOCKING SCREW STARDRIVE 22MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention