BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYETHYLENE INLAY

    MDR report key: 2042154 · Received March 28, 2011

    Report

    Report Number
    2530088-2011-00082
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 3, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBJECT DEVICE WAS NOT EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT HAS BEEN RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PATIENT STATUS POST PDL IMPLANTATION L4-5, L5-S1, IMPLANTED ON (B)(6) 2010 HEARD SOMETHING POP IN (B)(6) 2010. IN (B)(6) 2010, PATIENT EXPERIENCED INCREASED PAIN RETURNING TO SURGEON IN (B)(6) 2011. AN X-RAY SHOWED THE PRODISC-L POLYETHYLENE INLAY POPPED OUT ANTERIORLY AT L5-S1. SURGEON PERFORMED AN EPIDURAL ON (B)(6) 2011 AND IS MONITORING THE PATIENT. NO HARDWARE HAS BEEN REMOVED AT THIS TIME. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention INFERIOR ENDPLATE| SUPERIOR ENDPLATE