BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 24MM(16MM)

    MDR report key: 2992062 · Received March 7, 2013

    Report

    Report Number
    2530088-2013-10124
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    December 8, 2011
    Report Date
    January 9, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWQ
    PMA / PMN Number
    K971883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    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 FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION.

    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 FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS PUTTING IN THE 16MM CERVICAL SPINE LOCKING PLATE (CSLP) IN THE UPPER LEFT SCREW HOLE, THE SCREW HEAD OF ONE SCREW WENT THROUGH THE PLATE HOLE. HE HAD ALSO USED 3 SCREWS AND 2 LOCKING SCREWS. THE CONSTRUCT WAS REMOVED AND REPLACED. NO HARM TO THE PATIENT WAS NOTED. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96972 TI CERVICAL SPINE LOCKING PLATE/SMALL STATURE 24MM(16MM) KWQ SYNTHES BRANDYWINE 6702243

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR