BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 20MM

    MDR report key: 3082375 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-02254
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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

    PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT ON THE RIGHT FIBULA ON (B)(6) 2013. IT WAS REPORTED THAT POST-OPERATIVELY, PATIENT HAD SKIN ISSUES AT THE INCISION SITE. THE SKIN WAS NOT HEALING WELL, BUT THE BONE HEALED PROPERLY. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS HEALED, SO THE SURGEON DID NOT REVISE PATIENT WITH ANY OTHER HARDWARE. IT WAS REPORTED THAT PATIENT DID NOT HAVE AN INFECTION AND NONE OF THE PARTS WERE BROKEN. THE SURGEON COMPLETED THE HARDWARE REMOVAL PROCEDURE WITHOUT ANY ISSUES. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184069 2.4MM VA LOCKING SCREW STARDRIVE 20MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention