BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA POLYAXIAL SCREW

    MDR report key: 2032585 · Received March 23, 2011

    Report

    Report Number
    8030965-2011-00090
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    March 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS ONGOING, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM HOSPITAL (B)(6), INDICATES THAT THREE PANGEA HEADS POPPED OFF THE BONE SCREWS INSIDE THE PT. THE PT DID NOT SUFFER ANY TRAUMA THAT COULD HAVE LED TO THIS SITUATION. THE HEADS WERE REMOVED FROM THE PT. THIS REPORT IS #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA POLYAXIAL SCREW 6.0MM TI PANGEA POLYAXIAL SCREW KWP SYNTHES GMBH NA 6250208

    Patients

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