BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONG ANGL-UPWARDS W/4 L330

    MDR report key: 3193336 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02763
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 14, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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). A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION OF THE RETURNED INSTRUMENT HAS SHOWN THAT THE SCREW WAS INDEED BROKEN OFF. THE INSTRUMENT WAS SENT TO OUR REPAIR DEPARTMENT IN ORDER TO MAINTAIN OR REPAIR IT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND.

    Description of Event or Problem · 1

    DURING REMOVAL, SCREW BROKE OFF AND FELL OUT. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292228 RONG ANGL-UPWARDS W/4 L330 HTX SYNTHES GMBH T929902

    Patients

    Seq Age Sex Outcome Treatment
    1