BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L IMPLANT POLYETHYLENE INLAY

    MDR report key: 2041275 · Received March 29, 2011

    Report

    Report Number
    2520274-2011-00082
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 3, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER AND LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IDE PATIENT WAS IMPLANTED WITH PRODISC-L AT L5-S1 ON (B)(6) 2002. SURGEON NOTED THAT PARS DEFECT MAY HAVE BEEN PRESENT PREOPERATIVELY. INDEX LEVEL SURGERY FUSION PERFORMED ON (B)(6) 2004 TO ADDRESS PARS FRACTURE. REVISION SURGERY WAS PERFORMED ON (B)(6) 2006 FOR LOW BACK PAIN REQUIRING ANTERIOR DISCECTOMY AND FUSION AT L4-L5 WITH NUVASIVE PEEK GRAFT WITH BMP AT L4-L5, POSTERIOR FUSION AT L4-S1 WITH NUVASIVE PEDICLE SCREWS AND RODS AND PRODISC-L REMOVAL AT L5-S1 WITH POSTEROLATERAL BONE GRAFTING. PREOPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE AT L4-L5 WITH INSTABILITY AT L5-S1. 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 (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SUPERIOR ENDPLATE| INFERIOR ENDPLATE