BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CERVICAL SPINE LOCKING PLATE 48MM (40MM)

    MDR report key: 1910285 · Received November 23, 2010

    Report

    Report Number
    2520274-2010-00224
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. EXPLANTED HARDWARE WAS DISCARDED BY THE HOSPITAL. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CSLP PLATE AND SIX SCREWS APPROXIMATELY SEVEN YEARS PRIOR FOR AN ACDF AT C5-C7. PATIENT EXPERIENCED POSTOP DISCOMFORT AND AN MRI AND CT SCAN SHOWED A NON-UNION. PATIENT WAS RE-INSTRUMENTED FROM C3-C7 ON (B)(6) 2010. THE PLATE AND FIVE SCREWS WERE REMOVED. DURING SCREW REMOVAL ONE OF THE SCREW HEADS BROKE. THE SCREW SHAFT WAS NOT RETRIEVED AND REMAINS IN THE LEFT C7 VERTEBRAE. THE SURGEON NOTED THE SCREW SHAFT TO BE IN THE BONE WITH NO PROTRUSION. THIS IS THE 1ST OF 7 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CERVICAL SPINE LOCKING PLATE 48MM (40MM) LOCKING PLATE KWQ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCREWS