BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM

    MDR report key: 2251052 · Received September 12, 2011

    Report

    Report Number
    2530088-2011-00513
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. ADDITIONAL NARRATIVE: HAZARD 5.1 OF THE CURRENT RISK ANALYSIS FOR PRODISC-L DESCRIBES THE HAZARD OF DEVICE NOT EFFECTIVE RESULTING IN POTENTIAL HARMS OF CONTINUED PAIN AND POSSIBLE NEED FOR REOPERATION. CURRENT CONTROLS FOR THIS RISK INCLUDE SURGEON TRAINING AND SURGICAL TECHNIQUE DESCRIBING BIOMECHANICS, DEVICE DESIGN, PATIENT SELECTION, AND APPROPRIATE TECHNIQUES FOR CORRECT IMPLANTATION OF DEVICE. NOTE THAT SYNTHES REQUIRES ALL SURGEONS TO COMPLETE COMPREHENSIVE SURGEON TRAINING PRIOR TO USING THE PRODUCT. THIS TRAINING INVOLVES ONE DAY TRAINING BY EXPERT FACULTY AND INCLUDES HANDS-ON INSTRUCTION OF IMPLANTATION OF THE PRODISC-L DEVICE USING CADAVERIC MODELS. THE LISTED SEVERITY OF 4 AND AN OCCURRENCE RATE OF 3 ARE APPROPRIATE AND REPRESENTATIVE OF THIS COMPLAINT AND THE CLINICAL HISTORY TO DATE. CURRENT CONTROLS REMAIN APPROPRIATE, NO FURTHER MITIGATIONS NECESSARY. SEVERAL STUDIES REPORT CONTINUED OR PERSISTENT PAIN AS A POTENTIAL COMPLICATION OF LUMBAR DISC REPLACEMENT SURGERY. ALTHOUGH PAIN IS A DIFFICULT PARAMETER TO DEFINE AND CHARACTERIZE WITH RESPECT TO SURGICAL TREATMENT MODALITY, SOME MENTION OF FACET LOADING, ALTERED BIOMECHANICS, AND TREATMENT OF SYMPTOMS RATHER THAN DISEASE HAS BEEN MADE TO EXPLAIN POSSIBLE CONTRIBUTING FACTORS TO POST-SURGICAL PAIN FOLLOWING DISC REPLACEMENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AN NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH PRODISC-L AT L5-S1 IN 2009 WAS COMPLAINING OF TINGLING AND NUMBNESS IN THE TOES AND LEGS. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2011 FOR REMOVAL OF THE PRODISC-L AND REVISION TO A COMPETITIVE PLATE. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM MJO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR