BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CERVICAL SPINE LOCKING PLATE 77MM (69MM)

    MDR report key: 3012080 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10565
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IMPLANT DATE (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION, LEVEL C4-C7, SURGEON WAS INSERTING A 4.35 MM CANCELLOUS EXP HEAD SCREW INTO A CSLP PLATE C5 SCREW HOLE, AND THE SCREW HEAD WENT THROUGH THE PLATE. SURGEON INSERTED ANOTHER EIGHT SCREWS AND WENT TO REMOVE THE C5 SCREW THAT WENT THROUGH THE PLATE. SURGEON WAS UNSUCCESSFUL AT REMOVING THE SCREW, PLATE WAS BLOCKING THE REMOVAL, AND IT REMAINS IN THE PATIENT BONE. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115470 TI CERVICAL SPINE LOCKING PLATE 77MM (69MM) KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1