BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03999

    MDR report key: 3200864 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-03999
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN CORTEX SCREW THAT BACKED OUT POST-OPERATIVELY. THE PATIENT INITIALLY HAD SURGERY ON (B)(6) 2012 TO IMPLANT A DHS 6-HOLE PLATE, 6, 4.5MM ST CORTEX SCREWS AND A LAG SCREW FOR A SUBTROCHANTERIC FEMUR FRACTURE. IT WAS NOTED VIA X-RAY IN (B)(6) 2013, THAT 5 OUT OF THE 6 CORTEX SCREWS WERE BROKEN, 1 HAD PULLED OUT OF THE PLATE AND AN UNHEALED FRACTURE. THE LAG SCREW WAS REPORTED TO BE INTACT. THE PATIENT STATED THAT HE DID NOT FALL. THE PLATE AND ALL SCREWS WERE REMOVED AND THE PATIENT WAS REVISED TO A TFN NAIL CEPHALOMEDULLARY IMPLANT. NO OTHER ISSUES WERE REPORTED. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303211 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention