BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROSORB CR 8X 22 MM

    MDR report key: 504736 · Received January 2, 2004

    Report

    Report Number
    1030489-2003-00139
    Event Type
    Injury
    Date Received
    January 2, 2004
    Date of Event
    December 4, 2003
    Report Date
    December 18, 2003
    Manufacturer
    SOFAMOR DANEK - MEMPHIS
    Product Code
    JDK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGERY DATE: 2003. DURING ROUTINE POSTOPERATIVE X-RAYS IT WAS DISCOVERED THAT THE IMPLANT WAS BROKEN. EXPLANT SURGERY FOUR MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSORB CR 8X 22 MM CEMENT RESTRICTOR JDK SOFAMOR DANEK - MEMPHIS MSD527 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention