BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 40MM(32MM)

    MDR report key: 2973649 · Received February 22, 2013

    Report

    Report Number
    2530088-2013-00206
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 25, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. AN INVESTIGATION AND DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT IMPLANTED WITH A 2-LEVEL CSLP PLATE, 6 LOCKING SCREWS AND 6 SELF TAPPING EXPANSION SCREWS, DATE UNSPECIFIED. REPORTEDLY, IT WAS REVEALED THROUGH RADIOGRAPHIC IMAGING THAT THE PLATE AND TWO SCREWS WERE BROKEN. SUBSEQUENTLY, ON (B)(6) 2013, THE PATIENT RETURNED TO THE OR FOR REMOVAL OF ONE PLATE AND 6 LOCKING SCREWS AND 6 SELF TAPPING EXPANSION SCREWS. UPON REMOVAL, SEVERAL OF THE FLANGES FROM THE TOPS OF THE SCREWS ALSO CAME OUT, REPORTED AS SEPARATED FROM THE SCREW HEAD. AT LEAST TWO OF THE SCREWS HAD FLANGES DAMAGE AT THE TIME OF THIS REPORT. ADDITIONALLY, THE X-RAY REVEALS AT LEAST TWO BROKEN SCREWS. IT WAS REPORTED THAT AT LEAST ONE FRAGMENT OF A SCREW REMAINED IMPLANTED. IT WAS REPORTED THAT THE ANTICIPATED TREATMENT IS TO REVISE THE PATIENT WITH A NEW PLATE AND PEEK SPACER, NO DATE SPECIFIED. THIS IS REPORT NUMBER 5 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78670 TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 40MM(32MM) CERVICAL SPINE LOCKING PLATE KWQ SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention