BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172197 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01437
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, INJURY, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01438.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178248 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGJ00365

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| CALDERA T-SLING WITH CENTRASORB