BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI PANGEA LOCKING CAP

    MDR report key: 2111123 · Received May 25, 2011

    Report

    Report Number
    2530088-2011-00148
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 3, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LUMBAR LAMINECTOMY AND FUSION AT LEVELS L4-S1 WAS PERFORMED ON (B)(6)-2011. FOLLOW-UP VISIT WITH AN MRI SHOWED THAT THE ROD SHIFTED FORWARD AT L5-S1 INTERFACE. SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THERE ARE NO CURRENT PLANS FOR REVISION SURGERY. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SCREW| ROD