BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PANGEA(TM) LOCKING CAP

    MDR report key: 3123308 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02765
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K082572
    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

    IT IS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS A NONUNION OF THE L5 AND S1 VERTEBRAE APPROXIMATELY THREE YEARS AFTER SHE HAD BEEN IMPLANTED WITH AN L1 - S1 PANGEA CONSTRUCT. THE ENTIRE CONSTRUCT WAS REMOVED AND REPLACED. DURING IMPLANTATION OF THE NEW CONSTRUCT, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE RIGHT S1 SCREW. THE SCREW WOULD NOT ADVANCE, SO THE SURGEON INSTEAD USED A SHORTER SCREW. NO PATIENT HARM WAS REPORTED AND ABOUT 10 MINUTES WERE ADDED TO THE PROCEDURE. THIS IS REPORT 15 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224136 TI PANGEA(TM) LOCKING CAP NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention