BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM CANNULATED SCREW LONG THREAD/48MM

    MDR report key: 3241185 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04459
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SEEN FOR A POST 6 WEEK, RIGHT ANKLE FRACTURE FOLLOW-UP. THE EXAMINATION REVEALED A FIXATION FAILURE (NON-UNION). THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A LOCKING FIBULAR PLATE CONSTRUCT WITHOUT COMPLICATION. THE PATIENT WAS RECOVERING WITH NO COMPLICATIONS. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341804 4.0MM CANNULATED SCREW LONG THREAD/48MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention