BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II POLYAX SCRHOLDER3

    MDR report key: 3192630 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03486
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION OF THE COMPLAINED PART SHOWS THAT THE HOLDING-CLIP AND THE HEAD CAME OFF THE SCREW BODY. THE HOLDING CLIP IS SLIGHTLY DEFORMED; WITH THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE THE REASON. BASED ON THE DHR REVIEW, THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PART WAS EASILY SEPARATED BETWEEN BODY AND HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294073 USS-II POLYAX SCRHOLDER3 LXH SYNTHES GMBH 1845643

    Patients

    Seq Age Sex Outcome Treatment
    1