BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI PANGEA LOCKING CAP

    MDR report key: 2041276 · Received March 29, 2011

    Report

    Report Number
    2530088-2011-00096
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 12, 2010
    Report Date
    March 11, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE REPORTED AS (B)(6) 2009. INVESTIGATION IS ONGOING; 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 COMPLAINED OF PAIN (B)(6) 2010. X-RAYS SHOWED ROD SLIPPED OUT THE LEFT S1 SCREW HEAD FROM PLIF PROCEDURE (B)(6) 2009 L1-S1. PATIENT PRESENTED TO OPERATING ROOM FOR REVISION (B)(6) 2010. LEFT S1 SCREW AND ROD KEPT, LOCKING CAP REMOVED AND REPLACED. LOCKING CAP APPEARED NOT TO BE SEATED OR FINAL TIGHTENED. PATIENT COMPLAINED OF WORSENING PAIN ONE DAY POST-OP ((B)(6) 2010); LOW BACK AND LEFT SIDE PAIN. MRI AND CT SCAN DID NOT REVEAL ANY ISSUES. MOTION X-RAYS SHOWED ONE S1 SCREW LOOSE. PATIENT PRESENTED TO OPERATING ROOM FOR 2ND REVISION (B)(6) 2010. LEFT, RIGHT S1 SCREWS AND RIGHT L5 SCREW LOOSE. BOTH RODS, LOOSE SCREWS AND ALL LOCKING CAPS REPLACED. THIS IS THE 5TH OF 6 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 5686233

    Patients

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