BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MIRS POLYAXIAL SCREW BODY

    MDR report key: 2802961 · Received August 30, 2012

    Report

    Report Number
    8030965-2012-00722
    Event Type
    Injury
    Date Received
    August 30, 2012
    Report Date
    August 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K113044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT INITIAL SURGERY FOR DEGENERATIVE DISC DISEASE AT LEVELS L3-S1 ON (B)(6) 2012. POST-OPERATIVELY, THE PT EXPERIENCED PAIN AND WAS RETURNED TO SURGERY ON (B)(6) 2012. THE LOCKING CAPS ON THE RIGHT SIDE AT L5 AND S1 WERE NOTED AS BACKING OUT. THE SURGEON WAS ABLE TO RETIGHTEN AND RESEAT BOTH LOCKING CAPS. THIS IS THE 3RD OF 5 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MIRS POLYAXIAL SCREW BODY MIRS POLYAXIAL SCREW BODY NKB SYNTHES GMBH

    Patients

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