BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 30MM THREAD LENGTH

    MDR report key: 2881881 · Received December 20, 2012

    Report

    Report Number
    2530088-2012-01112
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES THAT WOULD BE ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A MATRIX CONSTRUCT AT L4-L5 ON AN UNKNOWN DATE. POST OPERATIVELY THE PATIENT PRESENTED WITH PAIN AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REVISION AND REMOVAL OF MATRIX HARDWARE. THIS REPORT IS #1 OF 10 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI CANN MATRIX POLYAXIALSCREW 30MM THREAD LENGTH 6.0MM TI CANN MATRIX POLYAXIALSCREW 30MM THRD LNTH NKB SYNTHES BRANDYWINE 6380002

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCREWS, RODS, CAPS