BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM

    MDR report key: 1872079 · Received October 11, 2010

    Report

    Report Number
    2530088-2010-00151
    Event Type
    Injury
    Date Received
    October 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. NUMBER PROVIDED WAS NOT A SYNTHES VALID LOT NUMBER. INVESTIGATION NOT COMPLETE, NO CONCLUSIONS CAN BE DRAWN. NO PRODUCT BEING RETURNED FOR INVESTIGATION, VALID LOT NUMBER NOT PROVIDED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT UNDERWENT PDC REMOVAL AT C4-5 DUE TO MECHANICAL NECK PAIN, CERVICAL KYPHOSIS, AND RADICULOPATHY. THE PDC WAS ORIGINALLY IMPLANTED DUE TO DISC HERNIATION AND NECK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT MEDIUM PRODISC-C MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention