BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1812706 · Received August 14, 2010

    Report

    Report Number
    3005739886-2010-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2010
    Date of Event
    December 29, 2009
    Report Date
    August 11, 2010
    Manufacturer
    SPINAL USA
    Product Code
    KWQ
    PMA / PMN Number
    K073240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (B)(4) SCREW WAS FOUND BROKEN DURING VIEWING OF X-RAYS FOR F/U REMOVAL SURGERY. THE SCREW IS NOT AVAILABLE FOR EVAL AND NO F/U INFO COULD BE OBTAINED FROM EITHER THE REP OR THE SURGEON, THEREFORE, NO CONCLUSIONS COULD BE MADE AT THIS TIME. PART WAS NOT RETURNED FOR EXAMINATION, ALTHOUGH SEVERAL ATTEMPTS WERE MADE BOTH BY E-MAIL AND PHONE. THE DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS CYCLICAL LOADING OF THE DEVICE OVER TIME. THESE PRECAUTIONS ARE STATED IN THE DIRECTIONS FOR USE SUPPLIED WITH THE DEVICE. AT THIS TIME THE COMPLAINT IS CONSIDERED CLOSED. ORIGINAL REVIEW OF MDR DETERMINATION DECISION TREE INDICATED NO REPORT WAS NECESSARY. AFTER REVIEWING COMPLAINT FILES, IT WAS DECIDED TO REPORT THE INCIDENT EVEN THOUGH PREVIOUS DETERMINATIONS INDICATED OTHERWISE.

    Description of Event or Problem · 1

    ONE (B)(4) SCREW WAS FOUND BROKEN DURING VIEWING OF X-RAYS FOR F/U REMOVAL SURGERY. INCIDENT WAS REPORTED BY THE INDEPENDENT REP ON (B)(6) 2010 AFTER SURGERY F/U. ORIGINAL REVIEW OF MDR DETERMINATION DECISION TREE INDICATED NO REPORT WAS NECESSARY. AFTER REVIEWING COMPLAINT FILES, IT WAS DECIDED TO REPORT THE INCIDENT EVEN THOUGH PREVIOUS DETERMINATIONS INDICATED OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KWQ SPINAL USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention