BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L IMPLANT - POLYETHYLENE INLAY

    MDR report key: 2024023 · Received February 15, 2011

    Report

    Report Number
    2530088-2011-00033
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 18, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH PRODISC-L ON (B)(6) 2008. PATIENT REPORTED THE FOLLOWING: CONTINUED PAIN FOR TWO YEARS. UNABLE TO WORK. DESCRIBES PAIN AS EQUAL BILATERALLY AND CENTERED IN LOWER EXTREMITIES. PAIN COMES AND GOES EQUALLY. DISTRACTION BRINGS THE PAIN OUT OF THE LEGS. MEDICATION DOES NOT WORK. PAIN FEELS LIKE A LOW-LEVEL VOLTAGE AND A CONSTANT FEELING OF THE ONSET OF A CHARLIE HORSE. PAIN IS AGGRAVATING AND STEALS COMPREHENSION AND FOCUS. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L IMPLANT - POLYETHYLENE INLAY PRODISC-L IMPLANT MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 INFERIOR PLATE| SUPERIOR PLATE