BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDL IMPLANT

    MDR report key: 2914140 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00096
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    November 9, 2012
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS DEVICE WAS NOT RETURNED AND PART NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM GERMANY INDICATES A PRODISC L IMPLANTED ON (B)(6) 2012 WAS EXPLANTED. PATIENT EXPERIENCED A PEDICEL FRACTURE, ON (B)(6) 2012 THE PRODISC L WAS REMOVED AND PATIENT WAS IMPLANTED WITH AN ALTERNATE DEVICE. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20695 PDL IMPLANT INFERIOR PLATE HSB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention PD INLAY, INFERIOR PLATE, SUPERIOR PLATE.