BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK TSRH

    MDR report key: 209609 · Received February 9, 1999

    Report

    Report Number
    MW1015659
    Event Type
    Injury
    Date Received
    February 9, 1999
    Date of Event
    September 3, 1998
    Report Date
    January 30, 1999
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A POSTERIOR SPINAL FUSION WITH INTERNAL FIXATION AT THE LUMBAR 4-LUMBAR 5 LEVEL ON 4/8/98. HE BEGAN HAVING INCREASED PAIN PRIOR TO HIS 9/3/98 VISIT, AND ON THAT DATE IT WAS NOTED THAT HIS RIGHT INTERNAL FIXATION ROD HAD BROKEN. HE WAS TAKEN BACK TO SURGERY TO REPLACE HIS ROD ON 10/7/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DANEK TSRH Implant TITANIUM 1/4 SPINAL ROD JDN DANEK MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R