BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PANGEA LOCKING CAP

    MDR report key: 2012829 · Received March 1, 2011

    Report

    Report Number
    2530088-2011-00045
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. D6: APPROXIMATE IMPLANT DATE WAS (B)(4) 2010. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH ROD, SCREWS AND LOCKING CAPS FOR A POSTERIOR SPINAL FUSION AT L3-S1 IN (B)(6) 2010. PATIENT COMPLAINED OF CONTINUED PAIN. FOLLOW UP X-RAYS DID NOT REVEAL ANY ISSUES WITH THE CONSTRUCT. PATIENT UNDERWENT RE-EXPLORATION FOR DECOMPRESSION ON (B)(6)2011. SURGEON BEGAN TO DISASSEMBLE CONSTRUCT ON PATIENT'S RIGHT SIDE. WHEN THE ROD WAS REMOVED SURGEON NOTICED THE SCREW HEAD AT S1 HAD POPPED OFF FROM THE SHAFT OF THE SCREW. WHILE THE SCREW AT L5 WAS BEING REMOVED, IT WAS NOTED THAT THE SCREW APPEARED TO BE LOOSE. SCREWS WERE REMOVED AND REPLACED AT S1 AND L5 AND ALL FOUR LOCKING CAPS WERE REMOVED AND REPLACED. THE SAME ROD WAS RE-IMPLANTED. PATIENT WAS BEGINNING TO FUSE. THIS IS THE 6TH OR 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI PANGEA LOCKING CAP PANGEA LOCKING CAP NKB SYNTHES BRANDYWINE NA 6083896

    Patients

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