BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 3193586 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03861
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT FELL FROM A HORSE ON (B)(6) 2012 AND WAS IMPLANTED WITH PLATES AND SCREWS ON (B)(6) 2012. PATIENT RETURNED TO SURGEON ON AN UNKNOWN DATE COMPLAINING OF PAIN. ON (B)(6) 2013 PATIENT RETURNED TO THE OR FOR REMOVAL OF 2 PLATES AND 15 SCREWS. IT IS NOT KNOWN IF PATIENT WAS REVISED TO ANY OTHER HARDWARE. THIS IS 11 OF 17 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292483 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention