BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERIOR END PLATE LARGE 11°-STERILE

    MDR report key: 4222667 · Received November 4, 2014

    Report

    Report Number
    2530088-2014-10346
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP050010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID REPORTED AS (B)(6). THIS REPORT IS FOR AN UNKNOWN PRO DISC L SUPERIOR END PLATE/UNKNOWN LOT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION PROCEDURE DONE ON (B)(6), 2014. THE PRO DISC L (PDL) IMPLANT WAS REMOVED BECAUSE THE SURGEON STATED THE HEIGHT OF THE PDL WAS TOO BIG, LIMITING THE DEVICE'S ABILITY TO MOVE. THE DEVICE WAS REMOVED EASILY AND THERE WERE NO REPORTED DEVICE ISSUES. THIS REPORT IS FOR AN UNKNOWN PRO DISC L SUPERIOR END PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706131 SUPERIOR END PLATE LARGE 11°-STERILE PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention