BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE

    MDR report key: 2962114 · Received February 14, 2013

    Report

    Report Number
    2530088-2013-00164
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    March 1, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PO50010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND IT INDICATES THAT THE CURRENT OCCURRENCE RATE FOR PATIENT PAIN IS NOT ASSOCIATED WITH OTHER LISTED FAILURE MODES (I.E. MIGRATION, INLAY EXPULSION, FRACTURES, ETC). CURRENT CONTROLS REMAIN APPROPRIATE, NO FURTHER MITIGATIONS NECESSARY. ALTHOUGH PAIN IS A DIFFICULT PARAMETER TO DEFINE AND CHARACTERIZE WITH RESPECT TO SURGICAL TREATMENT MODALITY, THE MENTION OF FACET LOADING, ALTERED BIOMECHANICS, AND TREATMENT OF SYMPTOMS MAY CONTRIBUTE TO POST-SURGICAL PAIN FOLLOWING DISC REPLACEMENT. IT SHOULD BE NOTED THAT THE REPORTED OCCURRENCE OF DEVICE RELATED PAIN INCLUDES SOME LEVEL OF PAIN, BUT DOES NOT SPECIFY THE AMOUNT OF PAIN. TYPICALLY THE AMOUNT OF PAIN DID NOT REQUIRE REOPERATION, AS THERE WAS ONLY ONE DEVICE REMOVAL ADVERSE EVENT THAT WAS DEVICE RELATED FOR BOTH CHARITE AND PRODISC-L RESPECTIVELY. ANTERIOR THIGH PAIN IS AN INHERENT RISK WITH BOTH FUSION AND NON-FUSION DEVICES. LOWER EXTREMITY PAIN IS CURRENTLY LISTED IN THE SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE PRODISC-L DEVICE, AND THE OVERALL RATE OF OCCURRENCE REPORTED ARE CONSISTENT WITH THE CLINICAL HISTORY TO DATE. BASED ON THE LIMITED INFORMATION PROVIDE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE FOR THE ANTERIOR THIGH PAIN. THE COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PRODISC LUMBAR ON (B)(6) 2012. IT IS REPORTED THAT PATIENT WAS EXPERIENCING POST-OPERATIVE ANTERIOR THIGH PAIN THREE MONTHS AFTER THE IMPLANT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64990 POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE POLYETHYLENE INLAY W/TANTALUM MARKER MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR