BEUDAMED
    FDA Adverse Event Summary report: N

    6.0MM TI CURVED SOFT ROD 80MM

    MDR report key: 2051462 · Received March 31, 2011

    Report

    Report Number
    1719045-2011-00152
    Date Received
    March 31, 2011
    Report Date
    March 21, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SURGEON PLANS TO REMOVE ALL HARDWARE ON (B)(6) 2011. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT IMPLANTED WITH RODS, PANGEA SCREWS AND LOCKING CAPS ON (B)(6) 2011 AT LEVELS L4-S1. REPORTEDLY, 1-2 WEEKS POSTOP, PT FELL AND STARTED COMPLAINING OF PAIN. F/U X-RAYS REVIEWED BY THE RADIOLOGIST SHOWED THAT RODS ON BOTH SIDES MIGRATED AT ALL 3 LEVELS CRANIALLY, TOWARDS THE HEAD. SURGEON PLANS TO REMOVE ALL HARDWARE ON (B)(6) 2011. THIS IS THE 14TH OF 14 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI CURVED SOFT ROD 80MM RODS (SPINE) NKB SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention RODS| LOCKING CAPS| SCREWS