BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3170427 · Received June 10, 2013

    Report

    Report Number
    3005751028-2013-00054
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE IDENTITY OF THE PRODUCT IS NOT KNOWN. INVESTIGATION IS BEING DONE TO DETERMINE THE PRODUCT'S IDENTITY AND REASON FOR REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A PATIENT THAT HAD RECEIVED A TM SPINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261363 UNK UNK ODP ZIMMER TRABECULAR METAL TECHNOLOGY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention