BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE HARDWARE

    MDR report key: 2801481 · Received October 23, 2012

    Report

    Report Number
    1030489-2012-01929
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    February 12, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY WITH HARDWARE IMPLANTATION. SOMETIME POST-OP, THE PATIENT COMPLAINED OF PAIN. PATIENT WAS GIVEN "LONG STANDING ANTIOBIOTIC TREATMENT". A REVISION WAS DONE TO REMOVE THE HARDWARE AND A SHORT TIME LATER, IT WAS REPORTED THAT A BIOPSY WAS DONE. PATIENT HAS SINCE RETURNED STILL COMPLAINING OF PAIN. SURGEON SUGGESTS IT COULD BE A REACTION TO THE IMPLANTS OR A "LOW GRADE INFECTION". FINAL DIAGNOSIS HAS NOT YET BEEN MADE. A SECOND REVISION SURGERY IS PLANNED TO REPLACE REMAINING HARDWARE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE HARDWARE APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other| R