BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA POLYAXIAL SCREW

    MDR report key: 1253447 · Received December 5, 2008

    Report

    Report Number
    2530088-2008-00065
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K052123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO DISCREPANCIES ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    PT IMPLANTED WITH TI PANGEA POLYAXIAL SCREWS AND TI CLICK'X PEDICLE SCREWS FOR LUMBAR INSTABILITY AT L3-L4 AND L4-L5. PATIENT COMPLAINED OF PAIN. DURING REVISION, SURGEON NOTED ALL SET SCREWS IN EACH OF THE PANGEA SCREW CAPS WERE LOOSE. ONE OF THE FOUR SET SCREWS HAD ALMOST COMPLETELY BACKED OUT OF THE PANGEA SCREW CAP ON THE LEFT SIDE AT L5. THE TWO CLICK'X PEDICLE SCREWS HAD FALLEN APART. ALL HARDWARE WAS REMOVED AND REPLACED WITH COMPETITOR HARDWARE. SURGEON ADDED ANOTHER LEVEL AT L5-S1. TI CURVED RODS REMAINED INTACT. THIS IS ONE (1) OF FOUR (4) REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA POLYAXIAL SCREW PANGEA POLYAXIAL SCREWS KWP SYNTHES BRANDYWINE NA 5259357

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention SCREWS| RODS