BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDL IMPLANT

    MDR report key: 2820519 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02911
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: (B)(6) 2011. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. WHILE THE COMPLAINT DESCRIPTION DESCRIBES THAT THE PRODISC-L HAS SLIPPED OR MIGRATED, IT IS UNCLEAR WHETHER THE COMPLAINT REFERS TO A LOSS OF PLATE FIXATION OR INLAY EXPULSION/DISLOCATION. SYNTHES REQUIRES ALL SURGEONS COMPLETE COMPREHENSIVE SURGEON TRAINING PRIOR TO USING THE PRODUCT. THIS SURGEON TRAINING INVOLVES ONE DAY TRAINING BY EXPERT FACULTY AND INCLUDES HANDS-ON INSTRUCTION OF IMPLANTATION OF THE PRODISC-L DEVICE USING CADAVERIC MODELS. A LITERATURE REVIEW WAS PERFORMED TO EVALUATE REPORTED POTENTIAL CAUSES OF ANTERIOR PLATE OR INLAY MIGRATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE FOR THE SLIPPING AND MIGRATION DESCRIBED IN THIS COMPLAINT CANNOT BE DETERMINED. POTENTIAL CAUSES COULD INCLUDE AN INCOMPLETELY LOCKED PE-INLAY, POTENTIAL TRAUMA, LIMITED POSTERIOR RELEASE WITH INCOMPLETE DENUCLEATION, OR ANTERIOR MISPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT EXPERIENCING PAIN, POST PRODISC L IMPLANTATION. THE PATIENT WAS IMPLANTED WITH 2-LEVEL PDL IN (B)(6) 2011. POST-OPERATIVELY, THE PATIENT HAS EXPERIENCED ON-GOING AND NOW INCREASING, PAIN IN THE LEG, BACK, AND HIP. ON AN UNKNOWN DATE, X-RAYS WERE TAKEN THAT REPORTEDLY SHOW THE PRODISC-L HAS SLIPPED OR MIGRATED. THE PATIENT HAS RECEIVED NERVE BLOCK INJECTIONS ON UNKNOWN DATES TO ALLEVIATE THE PAIN. THE NERVE BLOCK INJECTIONS WERE REPORTED TO BE UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS REPORT # 2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDL IMPLANT PRODISCL MJO

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention