BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 26MM

    MDR report key: 3242191 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04491
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 14, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    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 THAT THE PATIENT HAD SURGERY ON (B)(6) 2013 TO TREAT A TRANSVERSE FRACTURE OF THE RIGHT ACETABULUM. AFTER RETURNING HOME, THE PATIENT FELL AND RETURNED TO THE ER WITH A DISPLACED FRACTURE OF THE RIGHT ACETABULUM. ALL THE ORIGINAL HARDWARE WAS INTACT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2013 TO TREAT THE DISPLACED FRACTURE. ONE PLATE FROM THE ORIGINAL SURGERY AND FOURTEEN SCREWS WERE REMOVED. THE FRACTURE WAS REDUCED AND ADDITIONAL PLATES AND SCREWS WERE IMPLANTED TO STABILIZE THE FRACTURE. THIS IS REPORT 2 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343464 3.5MM CORTEX SCREW SELF-TAPPING 26MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention