BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK TITANIUM

    MDR report key: 282521 · Received June 16, 2000

    Report

    Report Number
    282521
    Event Type
    Injury
    Date Received
    June 16, 2000
    Date of Event
    May 17, 2000
    Report Date
    May 24, 2000
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HERE FOR REVISION OF LUMBAR FUSION. SCREW ON RIGHT SIDE SLIPPED OF END OF ROD. MEDICAL CENTER SUBMITS THIS REPORT PURSUANT TO THE PROVISION OF 21CFR PART 803. THIS REPORT IS BASED ON PRELIMINARY INFO RECEIVED BY THE MEDICAL CENTER WHICH HAS NOT HAD THE OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REPORTING DATE. MEDICAL CENTER HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THIS EVENT. IN ADDITION, THE SUBMISSION OF THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DANEK TITANIUM ROD AND SCREWS KWQ MEDTRONIC SOFAMOR DANEK 827-340, 89104EHT, 855-011 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 4. BREAKOFF SET SCREW X4,| 2. DANEK TITANIUM MULTI AXIAL SCREW IMPLANTS| CORTICAL WEDGE 12X26 X2 171226FD,| 3. 65X40 MAS X4,| 1. IMPLANTS: UNIV OF FLORIDA TISSUE BANK IMPACTED| 5. 5.5MM HEX-END ROD.| (TITANIUM).