BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA POLYAXIAL SCREW DUAL CORE

    MDR report key: 2655613 · Received July 6, 2012

    Report

    Report Number
    2530088-2012-00403
    Event Type
    Injury
    Date Received
    July 6, 2012
    Report Date
    June 8, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART NUMBERS AND LOT NUMBERS OF THE ENTIRE CONSTRUCT WERE PROVIDED. SYNTHES IS UNABLE TO DETERMINE WHICH OF THE 6 SCREWS AND THE CORRESPONDING LOT NUMBERS WERE IMPLANTED IN THE REPORTED VERTEBRAL BODIES OF L5 AND S1, THEREFORE, ALL CATALOG #S 6821666, 6883102; CATALOG # 04.620.645; LOT#S 6844781, 6706158, 6843947, 6810560. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH PANGEA CONSTRUCT FROM L4-S1 ON (B)(6) 2012. PT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PT HAD INCREASED LOW BACK PAIN. X-RAYS DEMONSTRATED THE RODS ON BOTH SIDES WERE DISLODGED AND LEFT L5 SCREW HEAD POPPED OFF. THE LEFT ROD OF THE CONSTRUCT TWISTED. THE SCREW AT LEFT L5 WAS STILL ATTACHED IN THE BONE. THE HEAD OF THE SCREW AT L5 POPPED OUT BUT WAS STILL ATTACHED TO THE ROD. THE ROD AT RIGHT S1 MIGRATED SUPERIORLY AND WAS PARTIALLY ENGAGED IN THE RIGHT S1 PEDICLE SCREW. SURGEON REMOVED ALL HARDWARE AND PT WAS REVISED TO MATRIX CONSTRUCT. THIS IS THE 4TH OF 5 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA POLYAXIAL SCREW DUAL CORE NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention LOCKING CAPS| RODS| SCREWS| LOCKING CAPS| SCREWS| RODS