BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2193338 · Received July 29, 2011

    Report

    Report Number
    2520274-2011-00526
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 8, 2011
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    (B)(6) STUDY FOR CHRONOS REPORTED THAT A PATIENT WITH A DEGENERATIVE DISC DISEASE WAS IMPLANTED WITH A MATRIX AND CHRONOS AT L4 - S1 ON (B)(6) 2011. AT FOLLOW UP VISIT ON (B)(6) 2011 IT WAS NOTED THAT THERE WAS INCISIONAL DISCHARGE AT THE SURGICAL SITE AND PATIENT EXPERIENCED FEBRILE EPISODE. PATIENT PROVIDED LEVAQUIN AND INSTRUCTED TO CLEANSE THE INCISION TWICE DAILY AND KEEP COVERED. THIS IS THE SECOND OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention CHRONOS