BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFT

    MDR report key: 888419 · Received August 1, 2007

    Report

    Report Number
    2249062-2007-00009
    Event Type
    Other
    Date Received
    August 1, 2007
    Date of Event
    July 1, 2007
    Report Date
    August 1, 2007
    Manufacturer
    MFT
    Product Code
    MBP
    PMA / PMN Number
    K060161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELL IN 2007 AND SUSTAINED ACUTE AND PAINFUL L2 AND L3 FRACTURES. THE NEXT MONTH, SHE WAS TREATED AT BOTH LEVELS WITH OPTIMESH 1500E DEVICES THAT WERE FILLED WITH AFT. THE SURGERY WAS UNREMARKABLE, BUT THE SURGEON REPORTED THAT THE PATIENT NEVER GOT GOOD PAIN RELIEF. ONE MONTH LATER, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH BOTH IMPLANTS AND THE BONE GRAFT WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFT ALLOGRAFT FILL TUBE MBP MFT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R LOT #: S06018) , SEE REPORT 2135156-2007-00002| TWO UNITS OPTIMESH 1500E (PRODUCT CODE: 330-2005,