BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI SIDE-OPENING SCREW 50MM

    MDR report key: 3030035 · Received April 2, 2013

    Report

    Report Number
    2530088-2013-00499
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    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 USS CONSTRUCT AT LEVELS L4-S1 ON (B)(6) 2009 FOR LUMBAR FUSION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY DUE TO ADJACENT LEVEL DISEASE AT L3-L3 AND L3-L4 LEVELS. SURGEON REMOVED ALL USS HARDWARE IMPLANTED AT L4-S1 LEVELS. PATIENT WAS REVISED TO USS DUAL OPENING CONSTRUCT AT L2-S1 LEVELS WITH THE EXCEPTION OF LEVEL L5 AS NO SCREWS WERE PLACED AT THIS LEVEL. REPORTEDLY, THE PATIENT WAS FUSED FROM LEVEL L4-S1. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THIS IS 18 OF 20 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133799 7.0MM TI SIDE-OPENING SCREW 50MM MNH SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention