BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI PANGEA POLYAXIAL SCREW

    MDR report key: 1903470 · Received November 15, 2010

    Report

    Report Number
    2530088-2010-00180
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    July 1, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SYNTHES USA BECAME AWARE ON (B)(4) 2010. WE ARE FILING THIS REPORT BASED ON THE DATE SYNTHES USA BECAME AWARE.

    Description of Event or Problem · 1

    A PT WAS IMPLANTED WITH A PANGEA CONSTRUCT FOR A SPONDYLOLISTHESIS AT L5-S1. TWO WEEKS LATER, ONE OF THE SCREW HEADS BROKE OFF AND ANOTHER SCREW BROKE OUT. THE PT WAS RETURNED TO THE OPERATING ROOM FOR REVISION WITH THE USS FRACTURE SYSTEM AT L4-L5-S1. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.0MM TI PANGEA POLYAXIAL SCREW 7.0MM TI PANGEA POLYAXIAL SCREW NKB SYNTHES BRANDYWINE NA 5149411

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention RODS| LOCKING CAPS| SCREWS